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

Myocardial Infarction Clinical Trial

— PREDICT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747656
• Other study ID #: HTA006-0708-01
• Status: Completed
• Phase: N/A
• First received: September 4, 2008
• Last updated: February 8, 2018
• Start date: February 2009
• Est. completion date: May 2013

Study information

• Verified date: February 2018
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
Canada	Stevenson Memorial Hospital	Alliston	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Sudbury Regional Hospital	Sudbury	Ontario
Canada	Rouge Valley	Toronto	Ontario
Canada	Sunnybrook Health Scineces Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival at 30 days		30 days
Secondary	Cost-effectiveness		1 year

External Links

•   Programs for Assessments of Technology in Health Research Institute