Coronariography in OUt of hosPital Cardiac arrEst (COUPE)

August 24, 2021 updated by: Ana Viana Tejedor, Hospital San Carlos, Madrid

Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.

Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited. Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, multicenter and randomized clinical trial. Survivors from Out-of-Hospital Cardiac Arrest (OHCA) who do not show ST elevation in their EKG will be recruited in the present study. Potentially non-cardiac ethiology of the cardiac arrest will be ruled out prior to randomization. Afterwards, patients will be randomized to emergent or deferred (performed before discharge) coronary angiography. Both groups will receive routine care in the Acute Cardiac Care Unit, including therapeutic hypothermia.

The randomization will be in a 1:1 ratio to urgent or deferred coronary angiography.

The main objective of the study is to compare the effectiveness of an urgent coronary angiography and angioplasty if necessary versus a deferred coronary angiography in survivors from OHCA who after recovery of spontaneous circulation do not fulfill criteria for ST-elevation myocardial infarction.

The primary efficacy endpoint is a composite of in-hospital survival and six-month survival free of severe dependence, which will be evaluated by using the Cerebral Performance Category (CPC) Scale, being good prognosis represented by the categories 1 and 2.The safety endpoint will be a composite of MACE (Major Adverse Cardiac Events) including: death, reinfarction, bleeding or ventricular arrhythmias.

A total of 166 patients will be included. The estimated duration will be 42 months, with a target follow-up of 6 months. Periods will be divided as follows:

  • Inclusion Period (selection of the population and data collection): 36 months.
  • Monitoring, data analysis, statistical and clinical report: 6 months.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: survivors from out of hospital cardiac arrest who meet all the following criteria:

  • Remain comatose after recovery of spontaneous circulation (ROSC) (Glasgow Coma Scale score equal or less than 8).
  • Show a non-diagnostic electrocardiogram after ROSC (neither ST segment elevation nor left bundle branch block).
  • Prior rule out of an obvious non-cardiac cause of the cardiac arrest (head CT scan and transthoracic echocardiogram).
  • Absence of exclusion criteria.

Exclusion Criteria:

  • Age <18 years.
  • Pregnant women or women of childbearing age unless they have a negative pregnancy test.
  • Time to return of spontaneous circulation longer than 60 minutes.
  • Non-cardiac etiology of the comatose state: drug overdose, head injury or stroke.
  • Acute myocardial infarction with ST segment elevation or left bundle branch block, because in those patients emergent angiography is mandatory.
  • Hemodynamic instability (refractory cardiogenic shock despite vasoactive drugs or refractory arrhythmias), because in those patients an emergent angiography is mandatory.
  • Known coagulopathy or bleeding.
  • Refusal to participate in the study by the next of kin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Urgent Coronary Angiography
Urgent Coronary Angiography: as soon as possible, when the patient is randomized.
Procedure: Urgent Coronary Angiography
Diagnostic test for the evaluation of the coronary vasculature.
Active Comparator: Deferred coronariography
Deferred coronary angiography: after extubation if the patient has a good neurologic prognosis.
Procedure: Deferred Coronary Angiography
Diagnostic test for the evaluation of the coronary vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Time Frame: 30 days.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
30 days.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Time Frame: 6 months.
Survival with good neurological outcome for activities of daily living (CPC 1-2).
6 months.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Time Frame: 30 days.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
30 days.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
Time Frame: 6 months.
MACE: death, myocardial infarction, clinically evident bleeding (BARC> 2) or ventricular arrhythmias.
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital survival.
Time Frame: 30 days.
Hospital survival.
30 days.
Hospital survival.
Time Frame: 6 months.
Hospital survival.
6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Time Frame: 30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC)
30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Time Frame: 6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC)
6 months.
Left ventricular ejection fraction.
Time Frame: 30 days.
Left ventricular ejection fraction.
30 days.
Left ventricular ejection fraction.
Time Frame: 6 months.
Left ventricular ejection fraction.
6 months.
Infarction size
Time Frame: 30 days.
Defined by the maximum CPK (creatine phosphokinase) and Troponin.
30 days.
Vascular complications.
Time Frame: 30 days.
Vascular complications such as pseudoaneurysms, arteriovenous fistulas, etc
30 days.
Clinically evident haemorrhagia: BARC> 2
Time Frame: 30 days.
Clinically evident haemorrhagia: BARC> 2
30 days.
Sustained ventricular arrythmias or requirement of cardioversion.
Time Frame: 30 days.
Sustained ventricular arrythmias or requirement of cardioversion.
30 days.
Renal impairment.
Time Frame: 30 days.
A 50% increase of serum creatinine over a baseline level or an increase of >0.5 mg/dl
30 days.
Reinfarction.
Time Frame: 30 days.
According to the Universal Definition of Acute Myocardial Infarction
30 days.
Stent Thrombosis
Time Frame: 30 days.
Defined by the Academic Research Consortium (ARC).
30 days.
Infections.
Time Frame: 30 days.
Infections.
30 days.
Length of intubation.
Time Frame: 30 days.
Length of intubation.
30 days.
Length of hospital stay.
Time Frame: 6 months.
Length of hospital stay.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Hospital Universitario Ramon y Cajal
Hospital Arnau de Vilanova
Hospital Universitario de Canarias
Hospital Universitario Virgen Macarena
Hospital Universitari de Bellvitge
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Universitari Joan XXIII de Tarragona.
Hospital Vall d'Hebron
Hospital Clínico Universitario de Valladolid
Institut d Investigación Biomedica Dr. Josep Trueta de Girona
Complejo Hospitalario Universitario de Santiago
Hospital Universitario Principe de Asturias
Hospital de Leon

Investigators

  • Principal Investigator: Ana Viana Tejedor, MD, PhD, Hospital Clínico San Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

December 20, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COUPE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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