Myocardial Infarction
Conditions
Keywords
STEMI, Primary PCI, Length of Stay, Early Discharge
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).
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.
Interventions
BEHAVIORALEarly hospital discharge facilitated by close nurse practitioner follow-up
Sponsors
McMaster University
Regional Medical Associates Research Scholarship Fund
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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%) | — |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed