- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00747656
Prehospital Evaluation and Economic Analysis of Different Coronary Syndrome Treatment Strategies - PREDICT (PREDICT)
February 8, 2018 updated by: Daria O'Reilly, St. Joseph's Healthcare Hamilton
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
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
446
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Alliston, Ontario, Canada, L9R 1W7
- Stevenson Memorial Hospital
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Newmarket, Ontario, Canada, L3Y 2P9
- Southlake Regional Health Centre
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Sudbury, Ontario, Canada, M4N 3M5
- Sudbury Regional Hospital
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Toronto, Ontario, Canada
- Rouge Valley
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Toronto, Ontario, Canada
- Sunnybrook Health Scineces Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Call 911 for assistance
- Are suspected by the paramedics of having ischemic chest pain for greater than 30 minutes but less than 6 hours
- Be greater than or equal to 18 years of age
- Experience chest pain that fails to completely respond to nitrates as per standard provincial chest pain protocol.
Exclusion Criteria:
- Subjects less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of the time from arrival to the ED to initiation of the reperfusion therapy between those receiving 12 lead PHECG and those receiving 3 lead PHECG monitoring prior to hospital arrival.
Time Frame: 24 hours
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost-effectiveness
Time Frame: 1 year
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1 year
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Survival at 30 days
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 4, 2008
First Submitted That Met QC Criteria
September 4, 2008
First Posted (Estimate)
September 5, 2008
Study Record Updates
Last Update Posted (Actual)
February 12, 2018
Last Update Submitted That Met QC Criteria
February 8, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTA006-0708-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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