Coronariography in OUt of hosPital Cardiac arrEst

Cardiac Arrest Clinical Trial

— COUPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641626
• Other study ID #: COUPE
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2021
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Urgent Coronary Angiography
Diagnostic test for the evaluation of the coronary vasculature.
• Deferred Coronary Angiography
Diagnostic test for the evaluation of the coronary vasculature.

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (17)

Lead Sponsor

Collaborator

Hospital San Carlos, Madrid

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

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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 — View Citation

Morrison 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 — View Citation

Outcome

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