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Completed

NCT Number: NCT00474214

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

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early hospital discharge facilitated by close nurse practitioner follow-up

Behavioral

Primary outcomes

  1. Safety: All-cause mortality

    Time frame: 6 weeks

  2. Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion

    Time frame: 6 weeks

  3. Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%)

  4. Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%)

  5. Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)

Secondary outcomes

  1. Quality of life, as measured by the SF-36 questionnaire

    Time frame: 6 weeks

  2. Compliance with medications

    Time frame: 6 weeks

  3. Compliance with smoking cessation

    Time frame: 6 weeks

  4. Attendance at first cardiac rehabilitation session

    Time frame: 6 weeks

  5. Cost-effectiveness

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University
  • Regional Medical Associates Research Scholarship Fund

Registry information

Official study title

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

Acronym: SAFE-DEPART

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 16, 2007
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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