We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876458
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 31, 2016
First Posted Date  ICMJE August 23, 2016
Last Update Posted Date October 12, 2021
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date November 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Out-of-Hospital Cardiac Arrest
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
336
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
970
Actual Study Completion Date  ICMJE November 23, 2020
Actual Primary Completion Date November 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02876458
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Christian Spaulding, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP