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

Primary Purpose

Out-of-Hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate coronary angiogram
Delayed coronary angiogram
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring Coronary angiogram, Survival rate, Neurological sequel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European Georges Pompidou Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate coronary angiogram

Delayed coronary angiogram

Arm Description

An immediate coronary angiogram will be performed

A delayed coronary angiogram (between 48 to 96 hours) will be performed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Shock
The rate of shock during the first 48 hours between immediate and delayed CA
Arrhythmia
The rate of VT/VF during the first 48 hours between immediate and delayed CA
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
CPC score
The rate of neurological sequel assessed by the CPC score between immediate and delayed CA
Glasgow Outcome Scale Extended score (GOSE)
The rate of neurological sequel assessed by the GOSE between immediate and delayed CA
Overall survival rate
The overall survival rate between immediate and delayed CA
Hospital stay length
The length of hospital stay between immediate and delayed CA

Full Information

First Posted
July 31, 2016
Last Updated
October 11, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02876458
Brief Title
EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest
Acronym
EMERGE
Official Title
EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Coronary angiogram, Survival rate, Neurological sequel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate coronary angiogram
Arm Type
Other
Arm Description
An immediate coronary angiogram will be performed
Arm Title
Delayed coronary angiogram
Arm Type
Other
Arm Description
A delayed coronary angiogram (between 48 to 96 hours) will be performed
Intervention Type
Other
Intervention Name(s)
Immediate coronary angiogram
Intervention Description
An immediate coronary angiogram will be performed
Intervention Type
Other
Intervention Name(s)
Delayed coronary angiogram
Intervention Description
A delayed coronary angiogram (between 48 to 96 hours) will be performed
Primary Outcome Measure Information:
Title
Survival with no or minimal neurological sequel
Description
Survival rate with no or minimal neurological sequel (CPC (cerebral performance category) 1 or 2) at 6 months after inclusion
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Shock
Description
The rate of shock during the first 48 hours between immediate and delayed CA
Time Frame
48 hours
Title
Arrhythmia
Description
The rate of VT/VF during the first 48 hours between immediate and delayed CA
Time Frame
48 hours
Title
The evolution of left ventricular ejection fraction evolution
Description
Changes in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram between immediate and delayed CA
Time Frame
180 days
Title
CPC score
Description
The rate of neurological sequel assessed by the CPC score between immediate and delayed CA
Time Frame
180 days
Title
Glasgow Outcome Scale Extended score (GOSE)
Description
The rate of neurological sequel assessed by the GOSE between immediate and delayed CA
Time Frame
180 days
Title
Overall survival rate
Description
The overall survival rate between immediate and delayed CA
Time Frame
180 days
Title
Hospital stay length
Description
The length of hospital stay between immediate and delayed CA
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Spaulding, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Georges Pompidou Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35675081
Citation
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.
Results Reference
derived

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

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