Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention (PCI) Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine if early hospital discharge (at 48-72 hours), is feasible, safe, cost-effective, and/or improves compliance with medications, positive lifestyle changes and quality-of-life, in low-risk patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention (primary PCI).

Detailed Description
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Patients with acute ST-segment elevation myocardial infarction (STEMI) have traditionally been hospitalized for at least 5-7 days to monitor for serious complications, including heart failure, arrhythmias, re-infarction and death. With the advent of primary percutaneous coronary intervention (PCI) as the treatment of choice for STEMI, fewer patients are completing their infarcts and the incidence of complications is decreasing. The Zwolle Primary PCI Index is one of several externally validated risk scores that can be used to identify low-risk primary PCI patients who can safely be discharged at 48-72 hours. Recent reviews have found that a majority of primary PCI patients with risk scores that deem them low-risk are kept in hospital longer than predicted by these scores. SAFE-DEPART is a trial where low-risk primary and rescue PCI patients will be randomized either to an intervention arm (early hospital discharge, early outpatient follow-up with a nurse practitioner) or to standard of care (no recommended discharge date, no outpatient follow-up with a nurse practitioner). At 6 weeks time, a blinded research assistant will contact patients and collect data on feasibility, safety, quality-of-life, and cost-effectiveness outcomes.

Official Title
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Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients (The SAFE-DEPART Trial)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Behavioral: Early hospital discharge facilitated by close nurse practitioner follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with ST-elevation myocardial infarction (STEMI) Treatment with either primary or rescue PCI Zwolle risk score <= 3 Exclusion Criteria: Developed MI while in hospital for another reason Time from angioplasty to enrollment > 24 hours
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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Early hospital discharge facilitated by close nurse practitioner follow-up|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: All-cause mortality |  | 6 weeks | 
| Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion |  | 6 weeks | 
| Feasibility: Proportion of patients in the intervention group discharged within 72 hours (feasible if >= 70%) |  |  | 
| Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge (feasible if >= 80%) |  |  | 
| Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge (feasible if >= 90%) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, as measured by the SF-36 questionnaire |  | 6 weeks | 
| Compliance with medications |  | 6 weeks | 
| Compliance with smoking cessation |  | 6 weeks | 
| Attendance at first cardiac rehabilitation session |  | 6 weeks | 
| Cost-effectiveness |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Primary PCI, Length of Stay, Early Discharge