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

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

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.

Study Overview

• Status: Completed
• Conditions: Out-of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: Immediate coronary angiogram; Other: Delayed coronary angiogram

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • European Georges Pompidou Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Immediate coronary angiogram; An immediate coronary angiogram will be performed	Other: Immediate coronary angiogram; An immediate coronary angiogram will be performed
OTHER: Delayed coronary angiogram; A delayed coronary angiogram (between 48 to 96 hours) will be performed	Other: Delayed coronary angiogram; A delayed coronary angiogram (between 48 to 96 hours) will be performed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Christian Spaulding, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Hauw-Berlemont C, Lamhaut L, Diehl JL, Andreotti C, Varenne O, Leroux P, Lascarrou JB, Guerin P, Loeb T, Roupie E, Daubin C, Beygui F, Boissier F, Marjanovic N, Christiaens L, Vilfaillot A, Glippa S, Prat JD, Chatellier G, Cariou A, Spaulding C; EMERGE Investigators. Emergency vs Delayed Coronary Angiogram in Survivors of Out-of-Hospital Cardiac Arrest: Results of the Randomized, Multicentric EMERGE Trial. JAMA Cardiol. 2022 Jul 1;7(7):700-707. doi: 10.1001/jamacardio.2022.1416.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): November 23, 2020
• Study Completion (ACTUAL): November 23, 2020

Study Registration Dates

• First Submitted: July 31, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (ESTIMATE): August 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Survival rate; Coronary angiogram; Neurological sequel
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Emergencies; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: P150914; 2016-A00413-48 (OTHER: ANSM); PHRC-15-15-0570 (OTHER_GRANT: French Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO