EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest
EMERGE
3 other identifiers
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2020
CompletedOctober 12, 2021
October 1, 2021
3.9 years
July 31, 2016
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Shock
48 hours
Arrhythmia
48 hours
The evolution of left ventricular ejection fraction evolution
180 days
CPC score
180 days
Glasgow Outcome Scale Extended score (GOSE)
180 days
- +2 more secondary outcomes
Study Arms (2)
Immediate coronary angiogram
OTHERAn immediate coronary angiogram will be performed
Delayed coronary angiogram
OTHERA delayed coronary angiogram (between 48 to 96 hours) will be performed
Interventions
An immediate coronary angiogram will be performed
A delayed coronary angiogram (between 48 to 96 hours) will be performed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Georges Pompidou Hospital
Paris, 75015, France
Related Publications (1)
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.
PMID: 35675081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Spaulding, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2016
First Posted
August 23, 2016
Study Start
January 1, 2017
Primary Completion
November 23, 2020
Study Completion
November 23, 2020
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share