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

Out-of-Hospital Cardiac Arrest Clinical Trial

— EMERGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876458
• Other study ID #: P150914
• Secondary ID: 2016-A00413-48PH
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 23, 2020

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Immediate coronary angiogram
An immediate coronary angiogram will be performed
• Delayed coronary angiogram
A delayed coronary angiogram (between 48 to 96 hours) will be performed

Locations

Country	Name	City	State
France	European Georges Pompidou Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Shock	The rate of shock during the first 48 hours between immediate and delayed CA	48 hours
Secondary	Arrhythmia	The rate of VT/VF during the first 48 hours between immediate and delayed CA	48 hours
Secondary	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	180 days
Secondary	CPC score	The rate of neurological sequel assessed by the CPC score between immediate and delayed CA	180 days
Secondary	Glasgow Outcome Scale Extended score (GOSE)	The rate of neurological sequel assessed by the GOSE between immediate and delayed CA	180 days
Secondary	Overall survival rate	The overall survival rate between immediate and delayed CA	180 days
Secondary	Hospital stay length	The length of hospital stay between immediate and delayed CA	180 days