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CTSN Embolic Protection Trial

Primary Purpose

Delirium, Ischemic Stroke, Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CardioGard Embolic Protection Cannula
Standard Aortic Cannula
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Embolic Protection, Cardiac Surgery, CardioGard

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 60 years Planned de novo or redo: Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG Mitral valve replacement (MVR) ± CABG Mitral Valve Repair + CABG, Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure. No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 days prior to randomization Ability to provide informed consent and comply with the protocol Exclusion Criteria Exclusion Criteria: History of clinical stroke within 3 months prior to randomization Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure Coronary catheterization within 3 days of the planned procedure Active endocarditis at time of randomization with vegetation criteria Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization Participation in an interventional (drug or device) trial Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator

Sites / Locations

  • CHI St. Vincent Heart Institute
  • Keck Hospital of the University of Southern California
  • Indiana Ohio Heart
  • Emory University
  • Indiana University
  • Ochsner Clinic
  • Maine Medical Center
  • Johns Hopkins Medicine
  • University of Maryland
  • Massachusetts General Hospital
  • University of Michigan
  • Saint Luke's Hospital of Kansas City
  • Montefiore Medical Center
  • Northwell HealthRecruiting
  • Duke University
  • Cleveland Clinic
  • Hospital of the University of Pennsylvania
  • Hôpital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CardioGard Embolic Protection Cannula

Standard Aortic Cannula

Arm Description

In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).

In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice

Outcomes

Primary Outcome Measures

Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Number of patients who experience of death and delirium
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).

Secondary Outcome Measures

Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 3 days post-randomization
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 7 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Hopkins Verbal Learning Test-Revised (HVLT-R) (verbal learning and memory) Score
HVLT-R is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome
Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
Brief Visuospatial Memory Test - Revised (visual learning & memory and constructional praxis)
Analogous to the HVLT-R, the Brief Visuospatial Memory Test (BVMT-R) assesses visual learning and memory by measuring how well individuals can recall a page of six line drawings presented visually for 10 seconds over three repetition trials. Examinee totals from the three repetition trials is taken as a measure of visual short-term learning and memory, and after a 20-minute delay, examinees are asked to reproduce as many as possible of the previously presented line drawings (assessing long-term visual memory retention and recall). Examinees are then shown 12 line drawings, six of which were the line drawings they were asked to reproduce earlier and six new drawings, and examinees are asked if they recognize the line drawings as ones they have seen before (assessing long-term visual recognition memory). Raw scores are converted to T-scores, normed by age and sex. A higher T-score representing a better outcome.
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Oral Trail Making Test - Parts A and B (executive function)
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Incidence of Delirium
The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU for intubated patients) during the first 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
Duration of Delirium
The duration of delirium will be measured as the number of days with positive CAM assessments by 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Severity of Delirium
The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
Number of Patients who experience Acute kidney injury (AKI)
Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
All-cause mortality
All-cause mortality within 90 days post-randomization will be assessed.
All-cause mortality
All-cause mortality within 12-months post-randomization will be assessed.
Length of Index Hospitalization
Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
Discharge disposition
Discharge disposition
Readmissions rates
Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Readmissions rates
Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Days Alive out of Hospital
Days alive out of hospital and nursing/rehab facilities within 90 days after randomization

Full Information

First Posted
August 21, 2023
Last Updated
October 10, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT06027788
Brief Title
CTSN Embolic Protection Trial
Official Title
Embolic Protection in Patients Undergoing High-Risk Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Detailed Description
This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure. RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned. STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease
Keywords
Embolic Protection, Cardiac Surgery, CardioGard

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the OR immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device).
Masking
Outcomes Assessor
Masking Description
The nature of the study precludes masking surgeons from treatment assignment. Investigators will, however, be blinded to all data from other clinical sites, except serious unexpected adverse events possibly or probably related to the intervention for Institutional Review Board (IRB)/Research Ethics Board (REB) reporting purposes. Patients will be blinded as to treatment assignment. All neurocognitive scoring and delirium assessments will be analyzed by neurocognitive core laboratory personnel who will be blinded to treatment assignment and clinical outcomes.
Allocation
Randomized
Enrollment
842 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CardioGard Embolic Protection Cannula
Arm Type
Active Comparator
Arm Description
In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).
Arm Title
Standard Aortic Cannula
Arm Type
Placebo Comparator
Arm Description
In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice
Intervention Type
Device
Intervention Name(s)
CardioGard Embolic Protection Cannula
Intervention Description
The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
Intervention Type
Device
Intervention Name(s)
Standard Aortic Cannula
Intervention Description
An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
Primary Outcome Measure Information:
Title
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Description
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Time Frame
within 3 days post-randomization
Title
Number of patients who experience of death and delirium
Description
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
Time Frame
by 7 days post-randomization
Secondary Outcome Measure Information:
Title
Proportion of patients who experience a clinical ischemic stroke
Description
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time Frame
within 3 days post-randomization
Title
Proportion of patients who experience a clinical ischemic stroke
Description
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Time Frame
within 7 days post-randomization
Title
Number of patients with disabling clinical stroke
Description
Number of patients with disabling clinical stroke within 3 days post-randomization
Time Frame
within 3 days post-randomization
Title
Number of patients with disabling clinical stroke
Description
Number of patients with disabling clinical stroke within 7 days post-randomization
Time Frame
within 7 days post-randomization
Title
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Description
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Time Frame
within 3 days post-randomization
Title
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Description
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery. Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment. These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Time Frame
within 7 days post-randomization
Title
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Description
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time Frame
at baseline
Title
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Description
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time Frame
at 30 days
Title
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Description
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.
Time Frame
at 90 days
Title
Montreal Cognitive Assessment (MoCA) Score
Description
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Time Frame
at baseline
Title
Montreal Cognitive Assessment (MoCA) Score
Description
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Time Frame
at 90 days
Title
Montreal Cognitive Assessment (MoCA) Score
Description
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months. The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Time Frame
at 12 months
Title
Hopkins Verbal Learning Test-Revised (HVLT-R) (verbal learning and memory) Score
Description
HVLT-R is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome
Time Frame
at baseline
Title
Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
Description
Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
Time Frame
at 90 days post-randomization
Title
Hopkins Verbal Learning Test-Revised (verbal learning and memory) Score
Description
Hopkins Verbal Learning Test-Revised (HVLT-R) is a structured word-list memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score for immediate recall and learning. Participants are also asked to recall learned word-list items after a 20-minute delay, yielding a delayed recall score. Participants also perform a subsequent recognition task where they affirm or deny recognition of the word-list materials (from a larger group of 12 target and 12 foil words), the results of which provide a score for recognition discriminability (i.e., target hits - foil misses). The scores for all of these HVLT-R variables are converted to standardized "T" scores using normative data. The possible "T" score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome.
Time Frame
at 12 months post-randomization
Title
Brief Visuospatial Memory Test - Revised (visual learning & memory and constructional praxis)
Description
Analogous to the HVLT-R, the Brief Visuospatial Memory Test (BVMT-R) assesses visual learning and memory by measuring how well individuals can recall a page of six line drawings presented visually for 10 seconds over three repetition trials. Examinee totals from the three repetition trials is taken as a measure of visual short-term learning and memory, and after a 20-minute delay, examinees are asked to reproduce as many as possible of the previously presented line drawings (assessing long-term visual memory retention and recall). Examinees are then shown 12 line drawings, six of which were the line drawings they were asked to reproduce earlier and six new drawings, and examinees are asked if they recognize the line drawings as ones they have seen before (assessing long-term visual recognition memory). Raw scores are converted to T-scores, normed by age and sex. A higher T-score representing a better outcome.
Time Frame
at 90 days post-procedure
Title
Oral Trail Making Test - Parts A and B (executive function)
Description
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame
at baseline
Title
Oral Trail Making Test - Parts A and B (executive function)
Description
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame
at 90 days post-randomization
Title
Oral Trail Making Test - Parts A and B (executive function)
Description
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame
at 12 months post-randomization
Title
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Description
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time Frame
baseline
Title
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Description
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time Frame
at 90 days post-randomization
Title
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Description
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Time Frame
at 12 months post-randomization
Title
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
Description
The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
Time Frame
at baseline
Title
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Description
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time Frame
at baseline
Title
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Description
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time Frame
at 90 days post-randomization
Title
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Description
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Time Frame
at 12 months post-randomization
Title
Incidence of Delirium
Description
The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU for intubated patients) during the first 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
Time Frame
first 7 days post-randomization
Title
Duration of Delirium
Description
The duration of delirium will be measured as the number of days with positive CAM assessments by 7 days post-randomization. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Time Frame
first 7 days post-randomization
Title
Severity of Delirium
Description
The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
Time Frame
first 7 days post-randomization
Title
Number of Patients who experience Acute kidney injury (AKI)
Description
Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
Time Frame
within -7 days post-randomization
Title
All-cause mortality
Description
All-cause mortality within 90 days post-randomization will be assessed.
Time Frame
within 90 days post-randomization
Title
All-cause mortality
Description
All-cause mortality within 12-months post-randomization will be assessed.
Time Frame
within 12 months post-randomization
Title
Length of Index Hospitalization
Description
Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
Time Frame
at hospital discharge, up to 30 days
Title
Discharge disposition
Description
Discharge disposition
Time Frame
at hospital discharge, up to 30 days
Title
Readmissions rates
Description
Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Time Frame
first 90 days
Title
Readmissions rates
Description
Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Time Frame
up to 1 year post-randomization
Title
Days Alive out of Hospital
Description
Days alive out of hospital and nursing/rehab facilities within 90 days after randomization
Time Frame
within 90 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 years Planned de novo or redo: Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG Mitral valve replacement (MVR) ± CABG Mitral Valve Repair + CABG, Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure. No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 days prior to randomization Ability to provide informed consent and comply with the protocol Exclusion Criteria Exclusion Criteria: History of clinical stroke within 3 months prior to randomization Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure Coronary catheterization within 3 days of the planned procedure Active endocarditis at time of randomization with vegetation criteria Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization Participation in an interventional (drug or device) trial Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Moquete
Phone
212-659-9651
Email
ellen.moquete@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Merlin
Phone
917-494-2387
Email
Claudia.merlin@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annetine C. Gelijns, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Messe, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Iribarne, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI St. Vincent Heart Institute
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Bass
Email
Lynn.bass@commonspirit.org
First Name & Middle Initial & Last Name & Degree
Thurston Bauer
Facility Name
Keck Hospital of the University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Lozano
Email
edwardlo@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Vaughn Starnes
Facility Name
Indiana Ohio Heart
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Anderson
Email
banderson2@lutheran-hosp.com
First Name & Middle Initial & Last Name & Degree
Vincent Scavo
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Mathewson
Email
sbmathe@emory.edu
First Name & Middle Initial & Last Name & Degree
Michael Halkos
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srdjan Kurbalija
Email
skurbalija@iuhealth.org
First Name & Middle Initial & Last Name & Degree
Joel Corvera
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolle Scholl
Email
nicolle.scholl@ochsner.org
First Name & Middle Initial & Last Name & Degree
Eugene Parrino
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Palmeri
Email
Monica.Palmeri@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Robert Kramer
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Fornaresio, PhD
Email
lisa.fornaresio@jhmi.edu
First Name & Middle Initial & Last Name & Degree
James S Gammie
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlyn Masih
Email
KMasih@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Mehrdad Ghoreishi
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Pico
Email
APICO@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Nathaniel Langer
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bret Weber
Email
bwe@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosann Gans
Email
rgans@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Keith Allen
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Siemienik
Email
asiemien@montefiore.org
First Name & Middle Initial & Last Name & Degree
Daniel Goldstein
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shangyi Liu
Email
sliu11@northwell.edu
First Name & Middle Initial & Last Name & Degree
Alexander Iribarne
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Fincannon
Email
shelly.fincannon@duke.edu
First Name & Middle Initial & Last Name & Degree
Peter Smith
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna M Simmons
Email
SIMMONA8@ccf.org
First Name & Middle Initial & Last Name & Degree
Marc Gillinov
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary L Mayer
Email
marylou.mayer@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Michael Acker
Facility Name
Hôpital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
QC G1V 4G5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Bergeron
Email
annie.bergeron@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Pierre Voisine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
IPD Sharing Access Criteria
Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/studies/

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