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

February 8, 2018 updated by: Daria O'Reilly, St. Joseph's Healthcare Hamilton

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Alliston, Ontario, Canada, L9R 1W7
        • Stevenson Memorial Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Sudbury, Ontario, Canada, M4N 3M5
        • Sudbury Regional Hospital
      • Toronto, Ontario, Canada
        • Rouge Valley
      • Toronto, Ontario, Canada
        • Sunnybrook Health Scineces Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cost-effectiveness
Time Frame: 1 year
1 year
Survival at 30 days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Joseph's Healthcare Hamilton

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HTA006-0708-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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