Back to resultsRemote Ischemic Preconditioning for Renal Protection in TAVI
Primary Purpose
Aortic Valve Stenosis, Renal Insufficiency, Contrast-induced Nephropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Control
Sponsored by
About this trial
This is an interventional prevention trial for Aortic Valve Stenosis
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention
Exclusion Criteria:
- Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
- Systemic hypotension (systolic blood pressure < 90mmHg)
- Patients currently on hemodialysis
- Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
- Patients enrolled in other active cardiovascular investigational studies
- Severe comorbidities with a life expectancy of less than 6 months
- Pregnant or lactating women
- Patients unable to provide consent
- Patients taking the medication glibenclamide for treatment of diabetes
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Control
Arm Description
This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.
This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.
Outcomes
Primary Outcome Measures
Renal function as a measured by serum creatinine
Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.
Secondary Outcome Measures
Clinical Outcomes
The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason.
Clinical Outcomes
The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission
Full Information
NCT ID
NCT03347032
First Posted
November 8, 2017
Last Updated
December 12, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03347032
Brief Title
Remote Ischemic Preconditioning for Renal Protection in TAVI
Official Title
Remote Ischemic Preconditioning for Renal Protection in Patients Undergoing Transcatheter Aortic Valve Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Renal Insufficiency, Contrast-induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
Serial inflations and deflations as detailed in the arm/group descriptions
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Serial inflations and deflations as detailed in the arm/group descriptions
Primary Outcome Measure Information:
Title
Renal function as a measured by serum creatinine
Description
Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.
Time Frame
48-72 hours
Secondary Outcome Measure Information:
Title
Clinical Outcomes
Description
The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason.
Time Frame
6 months
Title
Clinical Outcomes
Description
The investigators will be reviewing the medical records of participants for evidence of post procedure adverse events including death, MI, stroke and hospital readmission
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention
Exclusion Criteria:
Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
Systemic hypotension (systolic blood pressure < 90mmHg)
Patients currently on hemodialysis
Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
Patients enrolled in other active cardiovascular investigational studies
Severe comorbidities with a life expectancy of less than 6 months
Pregnant or lactating women
Patients unable to provide consent
Patients taking the medication glibenclamide for treatment of diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O'Neill, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remote Ischemic Preconditioning for Renal Protection in TAVI
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