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NCT Number: NCT02876458

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Georges Pompidou Hospital

Paris, 75015, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate coronary angiogram

Other

An immediate coronary angiogram will be performed

Delayed coronary angiogram

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Shock

    Time frame: 48 hours

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

  2. Arrhythmia

    Time frame: 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

    Time frame: 180 days

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

  4. CPC score

    Time frame: 180 days

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

  5. Glasgow Outcome Scale Extended score (GOSE)

    Time frame: 180 days

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

  6. Overall survival rate

    Time frame: 180 days

    The overall survival rate between immediate and delayed CA

  7. Hospital stay length

    Time frame: 180 days

    The length of hospital stay between immediate and delayed CA

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest

Acronym: EMERGE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2016
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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