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.
Sponsor:
Collaborators:
McMaster University
Regional Medical Associates Research Scholarship Fund
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00474214
First received: May 15, 2007
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474214

Locations
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
Investigators
Principal Investigator: Mark A Kotowycz, MD, MBA McMaster University
Principal Investigator: Madhu K Natarajan, MD Hamilton Health Sciences Corporation
  More Information

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

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014