NCT00474214

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

11 months

First QC Date

May 15, 2007

Last Update Submit

February 22, 2010

Conditions

Myocardial Infarction

Keywords

STEMIPrimary PCILength of StayEarly Discharge

Outcome Measures

Primary Outcomes (5)

  • Safety: All-cause mortality

    6 weeks

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

    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 Outcomes (5)

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

    6 weeks

  • Compliance with medications

    6 weeks

  • Compliance with smoking cessation

    6 weeks

  • Attendance at first cardiac rehabilitation session

    6 weeks

  • Cost-effectiveness

    6 weeks

Interventions

Early hospital discharge facilitated by close nurse practitioner follow-upBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with ST-elevation myocardial infarction (STEMI)
  • Treatment with either primary or rescue PCI
  • Zwolle risk score \<= 3

You may not qualify if:

  • Developed MI while in hospital for another reason
  • Time from angioplasty to enrollment \> 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20102876RESULT

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Mark A Kotowycz, MD, MBA

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Madhu K Natarajan, MD

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

CA(1)