Safety of Early Discharge Following Low Risk Myocardial Infarction

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: early discharge (<72 h)
* Other: Conventional discharge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early discharge (< 72 h)<br>Patients randomized the early discharge group will be discharged from the hospital in < 72 hours | Other: early discharge (<72 h)<br> <br> |
| Active Comparator: Conventional discharge<br>Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion | Other: Conventional discharge<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. | Composite primary end-point | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | According to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, primary percutaneous intervention, prognosis, early discharge