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

February 22, 2010 updated by: Hamilton Health Sciences Corporation

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (ESTIMATE)

May 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2010

Last Update Submitted That Met QC Criteria

February 22, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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