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

Not Applicable

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT00474214
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-16
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-22
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada