Safety of a Early Discharge Strategy in Patients With Low-risk ST-segment Elevation Myocardial Infarction Treated With Primary Coronary Intervention: a Randomized Controlled Trial

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country1,558 target enrollmentJanuary 2012

ConditionsMyocardial Infarction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myocardial Infarction
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment: 1558
Locations: 1
Primary Endpoint: All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
•Informed consent

Exclusion Criteria

•arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
•mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
•severe or moderate bleeding (according to the GUSTO criteria)
•complications related to vascular access of the procedure
•acute kidney failure
•infection
•heart failure