Myocardial IschemiaPREDICTNCT00747656
Prehospital Evaluation and Economic Analysis of Different Coronary Syndrome Treatment Strategies - PREDICT
An observational study of Myocardial Ischemia and Myocardial Infarction, run by St. Joseph's Healthcare Hamilton at 5 sites in Canada.
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Myocardial Infarction
- How many people
- 446 participants
- Where
- 5 sitesCanada
- Study dates
- Feb 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects less than 18 years of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Stevenson Memorial Hospital
Alliston, Ontario, L9R 1W7
Sudbury Regional Hospital
Greater Sudbury, Ontario, M4N 3M5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Rouge Valley
Toronto, Ontario
Sunnybrook Health Scineces Centre
Toronto, Ontario
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Ischemia, Myocardial Infarction
- Keywords
- Electrocardiography, Emergency medical services, Emergency medicine, Health services, Cost effectiveness
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
Survival at 30 days
Measured: 30 days
Cost-effectiveness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daria O'Reilly, St. Joseph's Healthcare Hamilton
- Investigators
- Laurie Morrison, MD, MSc, Principal investigator, Prehospital & Transport Medicine Research, Sunnybrook Health Sciences CentreRon Goeree, MA, Principal investigator, Programs for Assessments of Technology in Health Reasearch Institute, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747656
- Sponsor's protocol ID
- HTA006-0708-01
- Acronym
- PREDICT
- Status last verified
- Feb 2018
- First submitted
- 4 Sep 2008
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21447161
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00747656
- Acronym / sponsor ID
- PREDICT / HTA006-0708-01
- Conditions
- Myocardial Ischemia, Myocardial Infarction
- Keywords
- Electrocardiography, Emergency medical services, Emergency medicine, Health services, Cost effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Survival at 30 days
Time frame: 30 days
Cost-effectiveness
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 21447161Morrison 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.
- Programs for Assessments of Technology in Health Research InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Morrison, MD, MSc principal investigator
Prehospital & Transport Medicine Research, Sunnybrook Health Sciences Centre
Ron Goeree, MA principal investigator
Programs for Assessments of Technology in Health Reasearch Institute, St. Joseph's Healthcare Hamilton
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Myocardial Infarction, run by St. Joseph's Healthcare Hamilton at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.