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

Phase

N/A

Condition

Coronary Artery Disease

Myocardial Ischemia

Angina

Treatment

N/A

Clinical Study ID

NCT00474214

06-387

All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

January 01, 2007

December 31, 2007

Study 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.

Connect with a study center

Hamilton Health Sciences
Hamilton, Ontario L8L 2X2
Canada
Site Not Available

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