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Prehospital Evaluation and Economic Analysis of Different Coronary Syndrome Treatment Strategies - PREDICT

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ron Goeree, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00747656
First received: September 4, 2008
Last updated: May 7, 2013
Last verified: May 2013
  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
Myocardial Ischemia
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2009
Estimated Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
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
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
4
12 lead PHECG subjects with prehospital notification bypassed past the nearest receiving ED to the PCI center.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747656

Locations
Canada, Ontario
Stevenson Memorial Hospital
Alliston, Ontario, Canada, L9R 1W7
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Sudbury Regional Hospital
Sudbury, Ontario, Canada, M4N 3M5
Rouge Valley
Toronto, Ontario, Canada
Sunnybrook Health Scineces Centre
Toronto, Ontario, Canada
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
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
  More Information

Additional Information:
Publications:
Responsible Party: Ron Goeree, PI, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00747656     History of Changes
Other Study ID Numbers: HTA006-0708-01
Study First Received: September 4, 2008
Last Updated: May 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
Electrocardiography
Emergency medical services
Emergency medicine
Health services
Cost effectiveness

Additional relevant MeSH terms:
Coronary Artery Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014