Cardiac Catheterization in Cardiac Arrest

Study Overview
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Brief Summary
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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
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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

Official Title
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Role of Early Cardiac Catheterization in Cardiac Arrest

Conditions
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Out of Hospital Cardiac Arrest

Intervention / Treatment
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* Procedure: Cardiac catheterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early cardiac catheterization<br>Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia | Procedure: Cardiac catheterization<br>* 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<br>* Other names: Coronary angiography;|
| No Intervention: Medical arm<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 30 day | 
| CPC score |  | up to 30 days | 
| 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 | 48 hours | 
| 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. | 30 days | 
| 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 | 30 days | 
| Bleeding - according to Hb levels | Number of participant with overt bleeding according to Academic Research Consortium criteria | 30 days | 
| Composite of death and poor neurologic outcome |  | 1 year | 
| Stroke - imaging or pathology | New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging) | 30 days | 
| Heart failure (NYHA 3-4) |  | 30 days | 
| Estimated cost per patient according to length of stay and procedures performed |  | 30 days |