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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Diagnostic test for the evaluation of the coronary vasculature.
Diagnostic test for the evaluation of the coronary vasculature.
Hospital Clínico San Carlos
Madrid, Spain
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 6 months.
Hospital survival.
Hospital survival.
Time frame: 30 days.
Hospital survival.
Hospital survival.
Time frame: 6 months.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
Neurological outcome assessed by the Cerebral Performance Category (CPC)
Time frame: 30 days.
Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.
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Neurological outcome assessed by the Cerebral Performance Category (CPC)
Time frame: 6 months.
Left ventricular ejection fraction.
Left ventricular ejection fraction.
Time frame: 30 days.
Left ventricular ejection fraction.
Left ventricular ejection fraction.
Time frame: 6 months.
Infarction size
Defined by the maximum CPK (creatine phosphokinase) and Troponin.
Time frame: 30 days.
Vascular complications.
Vascular complications such as pseudoaneurysms, arteriovenous fistulas, etc
Time frame: 30 days.
Clinically evident haemorrhagia: BARC> 2
Clinically evident haemorrhagia: BARC\> 2
Time frame: 30 days.
Sustained ventricular arrythmias or requirement of cardioversion.
Sustained ventricular arrythmias or requirement of cardioversion.
Time frame: 30 days.
Renal impairment.
A 50% increase of serum creatinine over a baseline level or an increase of \>0.5 mg/dl
Time frame: 30 days.
Reinfarction.
According to the Universal Definition of Acute Myocardial Infarction
Time frame: 30 days.
Stent Thrombosis
Defined by the Academic Research Consortium (ARC).
Time frame: 30 days.
Infections.
Infections.
Time frame: 30 days.
Length of intubation.
Length of intubation.
Time frame: 30 days.
Length of hospital stay.
Length of hospital stay.
Time frame: 6 months.