Coronariography in OUt of hosPital Cardiac arrEst
COUPE
Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2015
CompletedFirst Posted
Study publicly available on registry
December 29, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedAugust 30, 2021
August 1, 2021
5.1 years
December 20, 2015
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Survival with good neurological outcome for activities of daily living (CPC 1-2).
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).
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.
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.
MACE: death, myocardial infarction, clinically evident bleeding (BARC\> 2) or ventricular arrhythmias.
6 months.
Secondary Outcomes (16)
Hospital survival.
30 days.
Hospital survival.
6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
6 months.
Left ventricular ejection fraction.
30 days.
- +11 more secondary outcomes
Study Arms (2)
Urgent Coronary Angiography
EXPERIMENTALUrgent Coronary Angiography: as soon as possible, when the patient is randomized.
Deferred coronariography
ACTIVE COMPARATORDeferred coronary angiography: after extubation if the patient has a good neurologic prognosis.
Interventions
Diagnostic test for the evaluation of the coronary vasculature.
Diagnostic test for the evaluation of the coronary vasculature.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital San Carlos, Madridlead
- Hospital Clínico Universitario de Valladolidcollaborator
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Paucollaborator
- Hospital Vall d'Hebroncollaborator
- Hospital Arnau de Vilanovacollaborator
- Hospital Universitari de Bellvitgecollaborator
- Hospital General Universitario Gregorio Marañoncollaborator
- Institut d'Investigació Biomèdica de Girona Dr. Josep Truetacollaborator
- Hospital Universitario Ramon y Cajalcollaborator
- Hospital Clinic of Barcelonacollaborator
- Hospital Universitario Virgen Macarenacollaborator
- Hospital Universitario de Canariascollaborator
- Germans Trias i Pujol Hospitalcollaborator
- Complejo Hospitalario Universitario de Santiagocollaborator
- Hospital Universitario Principe de Asturiascollaborator
- Hospital Universitari Joan XXIII de Tarragona.collaborator
- Hospital de Leoncollaborator
Study Sites (1)
Hospital Clínico San Carlos
Madrid, 28040, Spain
Related Publications (3)
Camuglia AC, Randhawa VK, Lavi S, Walters DL. Cardiac catheterization is associated with superior outcomes for survivors of out of hospital cardiac arrest: review and meta-analysis. Resuscitation. 2014 Nov;85(11):1533-40. doi: 10.1016/j.resuscitation.2014.08.025. Epub 2014 Sep 4.
PMID: 25195073RESULTMorrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Hoek TV, Halverson CC, Doering L, Peberdy MA, Edelson DP; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on P. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus statement from the American Heart Association. Circulation. 2013 Apr 9;127(14):1538-63. doi: 10.1161/CIR.0b013e31828b2770. Epub 2013 Mar 11. No abstract available.
PMID: 23479672RESULTViana-Tejedor A, Andrea-Riba R, Scardino C, Ariza-Sole A, Baneras J, Garcia-Garcia C, Jimenez Mena M, Vila M, Martinez-Selles M, Pastor G, Garcia Acuna JM, Loma-Osorio P, Garcia Rubira JC, Jorge Perez P, Pastor P, Ferrera C, Noriega FJ, Perez Macias N, Fernandez-Ortiz A, Perez-Villacastin J; COUPE Investigators. Coronary angiography in patients without ST-segment elevation following out-of-hospital cardiac arrest. COUPE clinical trial. Rev Esp Cardiol (Engl Ed). 2023 Feb;76(2):94-102. doi: 10.1016/j.rec.2022.05.013. Epub 2022 Jun 22. English, Spanish.
PMID: 35750580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Viana Tejedor, MD, PhD
Hospital Clinico San Carlos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD. PhD
Study Record Dates
First Submitted
December 20, 2015
First Posted
December 29, 2015
Study Start
January 1, 2016
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
August 30, 2021
Record last verified: 2021-08