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

NCT ID: NCT00747656

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Ischemia Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

4

12 lead PHECG subjects with prehospital notification bypassed past the nearest receiving ED to the PCI center.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Daria O'Reilly

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurie Morrison, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Prehospital & Transport Medicine Research, Sunnybrook Health Sciences Centre

Ron Goeree, MA

Role: PRINCIPAL_INVESTIGATOR

Programs for Assessments of Technology in Health Reasearch Institute, St. Joseph's Healthcare Hamilton

Locations

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Stevenson Memorial Hospital

Alliston, Ontario, Canada

Site Status

Sudbury Regional Hospital

Greater Sudbury, Ontario, Canada

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

Rouge Valley

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Scineces Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Morrison LJ, Rac VE, Bowen JM, Schwartz B, Perreira T, Ryan W, Zahn C, Chadha R, Craig A, O'Reilly D, Goeree R. Prehospital evaluation and economic analysis of different coronary syndrome treatment strategies--PREDICT--rationale, development and implementation. BMC Emerg Med. 2011 Mar 29;11:4. doi: 10.1186/1471-227X-11-4.

Reference Type BACKGROUND
PMID: 21447161 (View on PubMed)

Related Links

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http://www.path-hta.ca/

Programs for Assessments of Technology in Health Research Institute

Other Identifiers

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HTA006-0708-01

Identifier Type: -

Identifier Source: org_study_id

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