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Sponsors and Collaborators: |
Hamilton Health Sciences Regional Medical Associates Research Scholarship Fund |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | 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).
Condition | Intervention |
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Myocardial Infarction |
Behavioral: Early hospital discharge facilitated by close nurse practitioner follow-up |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-Risk Primary PCI Patients (The SAFE-DEPART Trial) |
Enrollment: | 54 |
Study Start Date: | January 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Hamilton Health Sciences | |
Hamilton, Ontario, Canada, L8L 2X2 |
Principal Investigator: | Mark A Kotowycz, MD, MBA | McMaster University |
Principal Investigator: | Madhu K Natarajan, MD | Hamilton Health Sciences |
Study ID Numbers: | 06-387 |
Study First Received: | May 15, 2007 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00474214 History of Changes |
Health Authority: | Canada: Health Canada |
STEMI Primary PCI Length of Stay Early Discharge |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |