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| Sponsored by: |
St. Joseph's Healthcare |
|---|---|
| Information provided by: | St. Joseph's Healthcare |
| ClinicalTrials.gov Identifier: | NCT00747656 |
Purpose
Despite remarkable gains in treatment over the last decade short-term mortality for those who survive to hospital with AT-elevation acute myocardial infarction (STEMI) remains high (5%-10%). Different studies have pointed out that reperfusion (intravenous fibrinolysis or percutaneous coronary interventions (PCI) and its timing are critical in decreasing STEMI patients' mortality. Studies of prehospital 12 lead electrocardiograms (12 lead PHECG) with advance emergency department (ED) notification suggest that there is a time to treatment advantage with this intervention. The use of 12 lead PHECG is not currently universal and part of standard treatment throughout the province. The purpose of the study is to follow STEMI study subjects during standard treatments and to compare the outcomes of subjects that received 12 lead PHECG with advanced ED notification in mixed rural/urban areas with outcomes of subjects treated in areas with only 3 lead PHECG monitoring and indirect ED notification. The investigators hypothesize that there will be a survival benefit for study subjects with 12 lead PHECG and advance ED notification in rural and urban environments through a reduction in door-to-reperfusion time and that 12 lead PHECG will be a cost-saving technology for the province of Ontario.
| Condition |
|---|
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Myocardial Ischemia Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | The Impact of Prehospital 12 Lead ECG With Advanced Emergency Department Notification on Time to in-Hospital Reperfusion Strategy in Patients With Acute ST Segment Elevation Myocardial Infarction - A Prospective Study |
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | February 2011 |
| Groups/Cohorts |
|---|
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1
3 lead ECG subjects with chest pain and suspected ischemia transported to the nearest receiving ED and not eligible for bypass based on transport time
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2
3 lead ECG subjects with chest pain and suspected ischemia transported to the nearest receiving ED and eligible for bypass based on transport time, if 12 lead PHECG was possible
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3
12 lead ECG subjects with prehospital notification transported to nearest receiving ED adn not eligible for bypass to PCI center based on transport time
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4
12 lead PHECG subjects with prehospital notification bypassed past the nearest receiving ED to the PCI center.
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Many studies have established that reperfusion reduces mortality in ST-elevation acute myocardial infarction (STEMI) patients; the earlier reperfusion therapy is delivered, the greater the mortality reduction. Most STEMI patient in Ontario still do not receive reperfusion therapy within established target times of <30 minutes for fibrinolysis or <90 minutes for PCI. 12 lead PHECG with advance ED notification may have a time to treatment impact in STEMI patients. However studies, investigating this intervention were all small, largely urban trials, and were carried out with advanced care paramedics. In Ontario, many emergency medical services (EMS) systems cover large rural regions, and are frequently staffed by primary care paramedics with only basic life support training. Thus, the benefit of 12 lead PHECG in these settings is unclear. In addition, no study has assessed the cost-effectiveness of 12 lead PHECG compared to 3 lead PHECG.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
This study will be conducted across Ontario. Selected regions representing approximately 17% of the population of Ontario and 6.4% of the popluation of Canada. Covering an area of 181426 per square kilometers with variable population densities from 2.5 to 234 person per square kilometers and representing rural, suburban, urban, and metropolis areas will be the catchment area for the study. A variety of EMS operators under the control of EMS Base Hospital programs will be involved in the data collection for this study. Patients presenting with suspected ischemic chest pain will be tracked as a part of the trial.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Valeria Rac, MD, PhD | 416-480-6100 ext 3386 | Valeria.Rac@sunnybrook.ca |
| Contact: James M. Bowen, BScPhm, MSc | 905-523-7284 ext 5279 | bowenj@mcmaster.ca |
| Canada, Ontario | |
| Southlake Regional Health Centre | Not yet recruiting |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Principal Investigator: Warren Cantor, MD | |
| Sudbury Regional Hospital | Recruiting |
| Sudbury, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: Collela, MD | |
| Stevenson Memorial Hospital | Not yet recruiting |
| Alliston, Ontario, Canada, L9R 1W7 | |
| Sunnybrook Health Scineces Centre | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Rouge Valley | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Laurie Morrison, MD, MSc | Prehospital & Transport Medicine Research, Sunnybrook Health Sciences Centre |
| Principal Investigator: | Ron Goeree, MA | Programs for Assessments of Technology in Health Reasearch Institute, St. Joseph's Healthcare Hamilton |
More Information
| Responsible Party: | Programs for Assessment of Technology in Health Research Institute ( Ron Goeree ) |
| Study ID Numbers: | HTA006-0708-01 |
| Study First Received: | September 4, 2008 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00747656 |
| Health Authority: | Canada: Health Canada |
|
Electrocardiography Emergency medical services Emergency medicine Health services Cost effectiveness |
|
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Emergencies Ischemia Infarction Myocardial Infarction |
|
Pathologic Processes Cardiovascular Diseases |
