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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stevenson Memorial Hospital, Alliston, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Survival at 30 days

Time frame: 30 days
Cost-effectiveness

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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

Acronym: PREDICT

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Sep 5, 2008
Registry last updated: Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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