Safety of Early Discharge Following Low Risk Myocardial Infarction

Not Applicable

• Conditions: Myocardial Infarction
• Interventions: Other: Conventional discharge; Other: early discharge (<72 h)

• Registration Number: NCT01868256
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-23
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-06-04
• Last Update Posted: 2013-06-04
• Primary Completion: 2014-01
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1558

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional discharge	Conventional discharge	Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion
Early discharge (< 72 h)	early discharge (<72 h)	Patients randomized the early discharge group will be discharged from the hospital in \< 72 hours

Primary Outcome Measures

Name	Time	Method
All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.	1 month	Composite primary end-point

Secondary Outcome Measures

Name	Time	Method
All cause mortality	1 month
Myocardial infarction	1 month
Unstable angina	1 month
Heart failure	1 month
Ventricular arrhythmias	1 month
Stroke	1 month
Severe bleeding	1 month	According to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain