Coronariography in OUt of hosPital Cardiac arrEst

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Procedure: Deferred Coronary Angiography; Procedure: Urgent Coronary Angiography

• Registration Number: NCT02641626
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-12-20
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deferred coronariography	Deferred Coronary Angiography	Deferred coronary angiography: after extubation if the patient has a good neurologic prognosis.
Urgent Coronary Angiography	Urgent Coronary Angiography	Urgent Coronary Angiography: as soon as possible, when the patient is randomized.

Primary Outcome Measures

Name	Time	Method
Survival with good neurological outcome for activities of daily living (CPC 1-2).	6 months.	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.	6 months.	MACE: death, myocardial infarction, clinically evident bleeding (BARC\> 2) or ventricular arrhythmias.

Secondary Outcome Measures

Name	Time	Method
Hospital survival.	6 months.	Hospital survival.
Left ventricular ejection fraction.	6 months.	Left ventricular ejection fraction.
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
Length of intubation.	30 days.	Length of intubation.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.	6 months.	Neurological outcome assessed by the Cerebral Performance Category (CPC)
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
Clinically evident haemorrhagia: BARC> 2	30 days.	Clinically evident haemorrhagia: BARC\> 2
Stent Thrombosis	30 days.	Defined by the Academic Research Consortium (ARC).
Infections.	30 days.	Infections.
Length of hospital stay.	6 months.	Length of hospital stay.

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain