- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02587494
Cardiac Catheterization in Cardiac Arrest
Role of Early Cardiac Catheterization in Cardiac Arrest
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mistre Alemayehu
- Phone Number: 519-6633611
- Email: mistre.alemayehu@lhsc.on.ca
Study Locations
-
-
Ontario
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London, Ontario, Canada, N6A5A5
- London Health Sciences Centre
-
Contact:
- Mistre Alemayehu, MSc
- Phone Number: 35625 519-685-8500
- Email: mistre.alemayehu@lhsc.on.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Early cardiac catheterization
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
|
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
Other Names:
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No Intervention: Medical arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: 30 day
|
30 day
|
|
CPC score
Time Frame: up to 30 days
|
up to 30 days
|
|
Acute kidney injury- creatinine levels
Time Frame: 48 hours
|
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
|
48 hours
|
Myocardial infarction - according to cardiac troponin levels
Time Frame: 30 days
|
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
|
30 days
|
Stent thrombosis by pathology or angiography
Time Frame: 30 days
|
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
|
30 days
|
Bleeding - according to Hb levels
Time Frame: 30 days
|
Number of participant with overt bleeding according to Academic Research Consortium criteria
|
30 days
|
Composite of death and poor neurologic outcome
Time Frame: 1 year
|
1 year
|
|
Stroke - imaging or pathology
Time Frame: 30 days
|
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
|
30 days
|
Heart failure (NYHA 3-4)
Time Frame: 30 days
|
30 days
|
|
Estimated cost per patient according to length of stay and procedures performed
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shahar Lavi, MD, London Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106834
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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