Coronariography in OUt of hosPital Cardiac arrEst

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02641626

Acronym

COUPE

Enrollment

Registered

2015-12-29

Start date

2016-01-31

Completion date

2021-01-31

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

cardiac arrest, survival, neurologic prognosis, coronariography, hypothermia

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.

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.

Interventions

PROCEDUREUrgent Coronary Angiography

Diagnostic test for the evaluation of the coronary vasculature.

PROCEDUREDeferred Coronary Angiography

Diagnostic test for the evaluation of the coronary vasculature.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026