EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest

Study Overview
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Brief Summary
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Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic. Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%). Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.

Detailed Description
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The design consists in a multicenter national randomized open parallel group trial. All eligible patients with SCD will be included and randomized by the Emergency Medical Service (EMS) to one of the 2 following arms: immediate CA vs delayed CA. Patients randomized in the immediate CA group will be admitted directly to the catheterization laboratory. Patients randomized in the delayed CA will be admitted to the intensive care unit and a CA will be planned 48 to 96 hours after admission. Investigators can perform the CA in the delayed group < 48 hours if the following events appear: ST segment elevation or new left bundle branch block on the ECG Shock unresponsive to inotropes Electrical storm (repeated Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)) Segmental hypokinesia or akinesia on an echocardiogram Echocardiography and assessment of neurological status are done at discharge form the Intensive Care Unit, at hospital discharge and during the follow-up visits (90 and 180 days).

Official Title
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EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest

Conditions
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Out-of-Hospital Cardiac Arrest

Intervention / Treatment
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* Other: Immediate coronary angiogram
* Other: Delayed coronary angiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital SCD with return of spontaneous circulation Age ≥ 18 years of age No obvious non-cardiac cause of arrest Admitted to a center with an intensive care unit and a 24 hours a day, 7 days a week interventional cardiology department Affiliation to the French Social Security Health Care plan Exclusion Criteria: Age < 18 years of age In-hospital SCD No return of spontaneous circulation Presence of ST segment elevation Suspected non-cardiac aetiology (trauma, respiratory, neurological, etc.) Presence of co-morbidities with life expectancy of less than a year Pregnancy Adults subject to a legal protection measure (guardianship or tutelage measure) Participation in another interventional trial

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 |
| --- | --- |
| Other: Immediate coronary angiogram<br>An immediate coronary angiogram will be performed | Other: Immediate coronary angiogram<br>* An immediate coronary angiogram will be performed<br>|
| Other: Delayed coronary angiogram<br>A delayed coronary angiogram (between 48 to 96 hours) will be performed | Other: Delayed coronary angiogram<br>* A delayed coronary angiogram (between 48 to 96 hours) will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with no or minimal neurological sequel | Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shock | The rate of shock during the first 48 hours between immediate and delayed CA | 48 hours | 
| Arrhythmia | The rate of VT/VF during the first 48 hours between immediate and delayed CA | 48 hours | 
| The evolution of left ventricular ejection fraction evolution | Changes in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram between immediate and delayed CA | 180 days | 
| CPC score | The rate of neurological sequel assessed by the CPC score between immediate and delayed CA | 180 days | 
| Glasgow Outcome Scale Extended score (GOSE) | The rate of neurological sequel assessed by the GOSE between immediate and delayed CA | 180 days | 
| Overall survival rate | The overall survival rate between immediate and delayed CA | 180 days | 
| Hospital stay length | The length of hospital stay between immediate and delayed CA | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary angiogram, Survival rate, Neurological sequel