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Trial record 1 of 1 for:    NCT02876458
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EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest (EMERGE)

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ClinicalTrials.gov Identifier: NCT02876458
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Out-of-Hospital Cardiac Arrest Other: Immediate coronary angiogram Other: Delayed coronary angiogram Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876458


Locations
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France
European Georges Pompidou Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Christian Spaulding, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02876458     History of Changes
Other Study ID Numbers: P150914
2016-A00413-48 ( Other Identifier: ANSM )
PHRC-15-15-0570 ( Other Grant/Funding Number: French Ministry of Health )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Coronary angiogram
Survival rate
Neurological sequel
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Emergencies
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases