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

NCT00747656 | Completed

• 1 other identifier: HTA006-0708-01
• Study Type: observational
• Target: 446
• Locations: 1 country
• Sites: 5

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.

Conditions

Myocardial Ischemia; Myocardial Infarction

Keywords

Electrocardiography; Emergency medical services; Emergency medicine; Health services; Cost effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survival at 30 days

  30 days

• Cost-effectiveness

  1 year

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects less than 18 years of age

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (5)

Stevenson Memorial Hospital

Alliston, Ontario, L9R 1W7, Canada

Location

Sudbury Regional Hospital

Greater Sudbury, Ontario, M4N 3M5, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Rouge Valley

Toronto, Ontario, Canada

Location

Sunnybrook Health Scineces Centre

Toronto, Ontario, Canada

Location

Related 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.

  PMID: 21447161 BACKGROUND

Related Links

• Programs for Assessments of Technology in Health Research Institute

MeSH Terms

Conditions

Myocardial Ischemia; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: February 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 12, 2018

Record last verified: 2018-02

Locations

CA (5)