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Coronariography in OUt of hosPital Cardiac arrEst (COUPE)

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ClinicalTrials.gov Identifier: NCT02641626
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Hospital Clínico Universitario de Valladolid
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Vall d'Hebron
Hospital Arnau de Vilanova
Hospital Universitari de Bellvitge
Hospital General Universitario Gregorio Marañon
Institut d Investigación Biomedica Dr. Josep Trueta de Girona
Hospital Universitario Ramon y Cajal
Hospital Clinic of Barcelona
Hospital Universitario Virgen Macarena
Hospital Universitario de Canarias
Germans Trias i Pujol Hospital
Complejo Hospitalario Universitario de Santiago
Hospital Universitario Principe de Asturias
Information provided by (Responsible Party):
Ana Viana Tejedor, Hospital San Carlos, Madrid

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Procedure: Urgent Coronary Angiography Procedure: Deferred Coronary Angiography Not Applicable

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 36 months, with a target follow-up of 6 months. Periods will be divided as follows:

  • Inclusion Period (selection of the population and data collection): 30 months.
  • Monitoring, data analysis, statistical and clinical report: 6 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Hospital survival. [ Time Frame: 30 days. ]
    Hospital survival.

  2. Hospital survival. [ Time Frame: 6 months. ]
    Hospital survival.

  3. Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale. [ Time Frame: 30 days. ]
    Neurological outcome assessed by the Cerebral Performance Category (CPC)

  4. Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale. [ Time Frame: 6 months. ]
    Neurological outcome assessed by the Cerebral Performance Category (CPC)

  5. Left ventricular ejection fraction. [ Time Frame: 30 days. ]
    Left ventricular ejection fraction.

  6. Left ventricular ejection fraction. [ Time Frame: 6 months. ]
    Left ventricular ejection fraction.

  7. Infarction size [ Time Frame: 30 days. ]
    Defined by the maximum CPK (creatine phosphokinase) and Troponin.

  8. Vascular complications. [ Time Frame: 30 days. ]
    Vascular complications such as pseudoaneurysms, arteriovenous fistulas, etc

  9. Clinically evident haemorrhagia: BARC> 2 [ Time Frame: 30 days. ]
    Clinically evident haemorrhagia: BARC> 2

  10. Sustained ventricular arrythmias or requirement of cardioversion. [ Time Frame: 30 days. ]
    Sustained ventricular arrythmias or requirement of cardioversion.

  11. Renal impairment. [ Time Frame: 30 days. ]
    A 50% increase of serum creatinine over a baseline level or an increase of >0.5 mg/dl

  12. Reinfarction. [ Time Frame: 30 days. ]
    According to the Universal Definition of Acute Myocardial Infarction

  13. Stent Thrombosis [ Time Frame: 30 days. ]
    Defined by the Academic Research Consortium (ARC).

  14. Infections. [ Time Frame: 30 days. ]
    Infections.

  15. Length of intubation. [ Time Frame: 30 days. ]
    Length of intubation.

  16. Length of hospital stay. [ Time Frame: 6 months. ]
    Length of hospital stay.



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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: 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.

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): NCT02641626


Contacts
Contact: Ana Viana Tejedor, MD, PhD +34 913303000 ext 7522 ana_viana_tejedor@hotmail.com
Contact: Carlos Ferrera Durán, MD, PhD +34 913303000 ext 7522 carlosferreraduran@gmail.com

Locations
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Ana Viana Tejedor, MD, PhD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
Hospital Clínico Universitario de Valladolid
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Vall d'Hebron
Hospital Arnau de Vilanova
Hospital Universitari de Bellvitge
Hospital General Universitario Gregorio Marañon
Institut d Investigación Biomedica Dr. Josep Trueta de Girona
Hospital Universitario Ramon y Cajal
Hospital Clinic of Barcelona
Hospital Universitario Virgen Macarena
Hospital Universitario de Canarias
Germans Trias i Pujol Hospital
Complejo Hospitalario Universitario de Santiago
Hospital Universitario Principe de Asturias
Investigators
Principal Investigator: Ana Viana Tejedor, MD, PhD Hospital Clinico San Carlos

Publications of Results:
Responsible Party: Ana Viana Tejedor, MD. PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT02641626     History of Changes
Other Study ID Numbers: COUPE
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Ana Viana Tejedor, Hospital San Carlos, Madrid:
cardiac arrest
survival
neurologic prognosis
coronariography
hypothermia

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases