Clinical trial NCT00474214: Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention (PCI) Patients
Official title: Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients (The SAFE-DEPART Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: STEMI
Primary PCI
Length of Stay
Early Discharge
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Regional Medical Associates Research Scholarship Fund
First posted: 2007-05-16
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: All-cause mortality
timeFrame: 6 weeks
measure: Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion
timeFrame: 6 weeks
measure: Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%)
measure: Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%)
measure: Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
Secondary outcomes:
measure: Quality of life, as measured by the SF-36 questionnaire
timeFrame: 6 weeks
measure: Compliance with medications
timeFrame: 6 weeks
measure: Compliance with smoking cessation
timeFrame: 6 weeks
measure: Attendance at first cardiac rehabilitation session
timeFrame: 6 weeks
measure: Cost-effectiveness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Mark A Kotowycz, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Madhu K Natarajan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK. Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial). Am Heart J. 2010 Jan;159(1):117.e1-6. doi: 10.1016/j.ahj.2009.10.024.