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

Sponsor

St. Joseph's Healthcare Hamilton (Other)

Overall Status

Completed

CT.gov ID

NCT00747656

Collaborator

(none)

446

Enrollment

Locations

50.9

Duration (Months)

89.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Myocardial Infarction

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 Design

Study Type:

Observational

Actual Enrollment :

446 participants

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

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. [24 hours]

Secondary Outcome Measures

Survival at 30 days [30 days]
Cost-effectiveness [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stevenson Memorial Hospital	Alliston	Ontario	Canada	L9R 1W7
2	Southlake Regional Health Centre	Newmarket	Ontario	Canada	L3Y 2P9
3	Sudbury Regional Hospital	Sudbury	Ontario	Canada	M4N 3M5
4	Rouge Valley	Toronto	Ontario	Canada
5	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