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

• ClinicalTrials.gov Identifier: NCT02876458
• Recruitment Status: Completed
• First Posted: August 23, 2016
• Last Update Posted: October 12, 2021
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 31, 2016
• First Posted Date: August 23, 2016
• Last Update Posted Date: October 12, 2021
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: November 23, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2016)

Survival with no or minimal neurological sequel [ Time Frame: 180 days ]

Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 18, 2016)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Out-of-Hospital Cardiac Arrest

Intervention

• 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

Study Arms

• Immediate coronary angiogram
  An immediate coronary angiogram will be performed
  Intervention: Other: Immediate coronary angiogram
• Delayed coronary angiogram
  A delayed coronary angiogram (between 48 to 96 hours) will be performed
  Intervention: Other: Delayed coronary angiogram

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2019): 336
• Original Estimated Enrollment (submitted: August 18, 2016): 970
• Actual Study Completion Date: November 23, 2020
• Actual Primary Completion Date: November 23, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02876458
• Other Study ID Numbers: P150914; 2016-A00413-48 ( Other Identifier: ANSM ); PHRC-15-15-0570 ( Other Grant/Funding Number: French Ministry of Health )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Ministry of Health, France

Investigators

• Principal Investigator: Christian Spaulding, MD, PhD; Assistance Publique - Hôpitaux de Paris

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2021