Randomized Study About the Efficacy of an Urgent Coronariography in Patients With a Non-diagnostic Electrocardiogram Following Out of Hospital Cardiac Arrest.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Survival with good neurological outcome for activities of daily living (CPC 1-2).
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Survival with good neurological outcome for activities of daily living (CPC 1-2).
Time Frame: 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.
Time Frame: 6 months.
MACE: death, myocardial infarction, clinically evident bleeding (BARC\> 2) or ventricular arrhythmias.
Secondary Outcomes
- Hospital survival.(6 months.)
- Left ventricular ejection fraction.(6 months.)
- Sustained ventricular arrythmias or requirement of cardioversion.(30 days.)
- Renal impairment.(30 days.)
- Reinfarction.(30 days.)
- Length of intubation.(30 days.)
- Neurological outcome assessed by the Cerebral Performance Category (CPC) Scale.(6 months.)
- Infarction size(30 days.)
- Vascular complications.(30 days.)
- Clinically evident haemorrhagia: BARC> 2(30 days.)
- Stent Thrombosis(30 days.)
- Infections.(30 days.)
- Length of hospital stay.(6 months.)
Investigators
Ana Viana Tejedor
MD. PhD
Hospital San Carlos, Madrid