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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT02876458
Collaborator
Ministry of Health, France (Other)
336
1
2
46.7
7.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immediate coronary angiogram
  • Other: Delayed coronary angiogram
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Nov 23, 2020
Actual Study Completion Date :
Nov 23, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Survival with no or minimal neurological sequel [180 days]

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

Secondary Outcome Measures

  1. Shock [48 hours]

    The rate of shock during the first 48 hours between immediate and delayed CA

  2. Arrhythmia [48 hours]

    The rate of VT/VF during the first 48 hours between immediate and delayed CA

  3. The evolution of left ventricular ejection fraction evolution [180 days]

    Changes in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram between immediate and delayed CA

  4. CPC score [180 days]

    The rate of neurological sequel assessed by the CPC score between immediate and delayed CA

  5. Glasgow Outcome Scale Extended score (GOSE) [180 days]

    The rate of neurological sequel assessed by the GOSE between immediate and delayed CA

  6. Overall survival rate [180 days]

    The overall survival rate between immediate and delayed CA

  7. Hospital stay length [180 days]

    The length of hospital stay between immediate and delayed CA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 European Georges Pompidou Hospital Paris France 75015

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Ministry of Health, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02876458
Other Study ID Numbers:
  • P150914
  • 2016-A00413-48
  • PHRC-15-15-0570
First Posted:
Aug 23, 2016
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021