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

This study has been completed.
McMaster University
Regional Medical Associates Research Scholarship Fund
Information provided by:
McMaster University Identifier:
First received: May 15, 2007
Last updated: February 22, 2010
Last verified: February 2010
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).

Condition Intervention
Myocardial Infarction
Behavioral: Early hospital discharge facilitated by close nurse practitioner follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients (The SAFE-DEPART Trial)

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Safety: All-cause mortality [ Time Frame: 6 weeks ]
  • Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion [ Time Frame: 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:
  • Quality of life, as measured by the SF-36 questionnaire [ Time Frame: 6 weeks ]
  • Compliance with medications [ Time Frame: 6 weeks ]
  • Compliance with smoking cessation [ Time Frame: 6 weeks ]
  • Attendance at first cardiac rehabilitation session [ Time Frame: 6 weeks ]
  • Cost-effectiveness [ Time Frame: 6 weeks ]

Enrollment: 54
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00474214

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Regional Medical Associates Research Scholarship Fund
Principal Investigator: Mark A Kotowycz, MD, MBA McMaster University
Principal Investigator: Madhu K Natarajan, MD Hamilton Health Sciences Corporation
  More Information

Publications: Identifier: NCT00474214     History of Changes
Other Study ID Numbers: 06-387
Study First Received: May 15, 2007
Last Updated: February 22, 2010

Keywords provided by McMaster University:
Primary PCI
Length of Stay
Early Discharge

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 25, 2017