Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
NCT Number: NCT00474214
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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Interventional
Not applicable
Hamilton, Ontario, L8L 2X2, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Hamilton Health Sciences Corporation
Other
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary PCI Patients (The SAFE-DEPART Trial)
Acronym: SAFE-DEPART
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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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