Cardiac Catheterization in Cardiac Arrest
Primary Purpose
Out of Hospital Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiac catheterization
Sponsored by
About this trial
This is an interventional treatment trial for Out of Hospital Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Exclusion Criteria:
- ST-elevation on any of the ECGs post resuscitation
- Hypothermia <30°C
- Interval from ROSC to screening of >12h
- Suspected or known acute intracranial hemorrhage or stroke
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Early cardiac catheterization
Medical arm
Arm Description
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.
Outcomes
Primary Outcome Measures
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Secondary Outcome Measures
Death
CPC score
Acute kidney injury- creatinine levels
Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
Myocardial infarction - according to cardiac troponin levels
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
Stent thrombosis by pathology or angiography
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
Bleeding - according to Hb levels
Number of participant with overt bleeding according to Academic Research Consortium criteria
Composite of death and poor neurologic outcome
Stroke - imaging or pathology
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
Heart failure (NYHA 3-4)
Estimated cost per patient according to length of stay and procedures performed
Full Information
NCT ID
NCT02587494
First Posted
August 27, 2015
Last Updated
August 22, 2017
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02587494
Brief Title
Cardiac Catheterization in Cardiac Arrest
Official Title
Role of Early Cardiac Catheterization in Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
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
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.
Detailed Description
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out of Hospital Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early cardiac catheterization
Arm Type
Active Comparator
Arm Description
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
Arm Title
Medical arm
Arm Type
No Intervention
Arm Description
Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.
Intervention Type
Procedure
Intervention Name(s)
Cardiac catheterization
Other Intervention Name(s)
Coronary angiography
Intervention Description
Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
Primary Outcome Measure Information:
Title
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Death
Time Frame
30 day
Title
CPC score
Time Frame
up to 30 days
Title
Acute kidney injury- creatinine levels
Description
Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
Time Frame
48 hours
Title
Myocardial infarction - according to cardiac troponin levels
Description
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
Time Frame
30 days
Title
Stent thrombosis by pathology or angiography
Description
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
Time Frame
30 days
Title
Bleeding - according to Hb levels
Description
Number of participant with overt bleeding according to Academic Research Consortium criteria
Time Frame
30 days
Title
Composite of death and poor neurologic outcome
Time Frame
1 year
Title
Stroke - imaging or pathology
Description
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
Time Frame
30 days
Title
Heart failure (NYHA 3-4)
Time Frame
30 days
Title
Estimated cost per patient according to length of stay and procedures performed
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Exclusion Criteria:
ST-elevation on any of the ECGs post resuscitation
Hypothermia <30°C
Interval from ROSC to screening of >12h
Suspected or known acute intracranial hemorrhage or stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahar Lavi, MD
Phone
519-6633611
Email
shahar.lavi@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mistre Alemayehu
Phone
519-6633611
Email
mistre.alemayehu@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Phone
519-663-3611
Email
shahar.lavi@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Mistre Alemayehu, MSc
Phone
519-685-8500
Ext
35625
Email
mistre.alemayehu@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
12. IPD Sharing Statement
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Cardiac Catheterization in Cardiac Arrest
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