EDAMI: Safety of Early Discharge Following Low Risk Myocardial Infarction

Sponsor

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

Overall Status

Unknown status

CT.gov ID

NCT01868256

Collaborator

(none)

1,558

Enrollment

Location

Arms

Duration (Months)

62.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: early discharge (<72 h) Other: Conventional discharge	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1558 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Early discharge (< 72 h)

Patients randomized the early discharge group will be discharged from the hospital in < 72 hours

Other: early discharge (<72 h)

Active Comparator: Conventional discharge

Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion

Other: Conventional discharge

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Difference in quality of life and functional capacity questionnaire SF-36. [1 month]
Compliance of treatment [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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