Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest

Study Overview
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Brief Summary
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The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.

Detailed Description
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The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.

Official Title
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Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study

Conditions
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Out-of-Hospital Cardiac Arrest

Intervention / Treatment
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* Procedure: Immediate coronary angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed out of hospital cardiac arrest Restoration of Spontaneous Circulation (ROSC) >20 minutes Coronary angiography is expected to be performed within 120 minutes from inclusion and randomization at hospital Exclusion Criteria: Patient age <18 years Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock, and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke) Terminally ill patients with a life expectancy of less than 1 year Patients with ST-elevation Known pregnancy Patient awake GCS >8 (Glasgow Coma Scale)

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 |
| --- | --- |
| Experimental: Immediate coronary angiography<br>Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC | Procedure: Immediate coronary angiography<br>* Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC<br>|
| No Intervention: Not immediate coronary angiography<br>Coronary angiography with possible coronary intervention may be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day survival | Follow up will be performed at 30 days, telephone call or visit. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with good neurological function | 30-day survival and a follow up of health status, functional outcome associated to cerebral performance and general functional outcome/activities of daily living | 30 days | 
| Survival at discharge from ICU (individual for each subject) and at 6-months | Recorded in the e-CRF (electronic Case Report Form) | At discharge from ICU, an expected average of 3-30 days and at 6-months | 
| Survival with good neurological function at discharge from ICU and 6-months | Survival with good neurological function at discharge and at 6-months. Assessing functional outcome associated to cerebral performance and general functional outcome/activities of daily living and also global functional outcome, independent living and social reintegration at 6-months | At discharge from ICU, an expected average of 3-30 days and at 6-months | 
| Cardiac function | Measured with echocardiography | 72 hours and at 6 months | 
| Follow up of neurological function at 6-months | A 6 month follow up of neurological function will be assessed by validated screening battery in OHCA (Out of Hospital Cardiac Arrest) patients in general functional outcome, activities of daily living, cognitive functioning, attention, anxiety and depression, fatigue, cardiac disease specific health and care giver burden. | Measured at 6 months | 
| Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support) | Parameters measured daily during ICU care | During ICU care (maximum of 7 days) | 
| ECG findings compared to findings at coronary angiography | Primary ECG, performed in the pre-hospital setting or at the emergency department, will be compared with findings at coronary angiography intervention (performed immediately or later during hospital stay depending on randomisation) | During hospital stay up to a maximum of 6-months |