1. What is this study?
PREDICT study is a non interventional study, observational study that will assist us to develop a comprehensive WEB based database with respect to the current standard of care offered to ACS – STEMI patients in the province of Ontario and the advantages of certain type of patient management. Currently there is a lack of comprehensive dataset for this group of patients and this study will enable us to bridge that gap and to provide beneficial feedback to EMS services and basehospitals. PREDICT study will create a comprehensive population based ACS data base, similar to Epistry for Cardiac Arrest and Lifethreatening trauma (currently in use with Hamilton, Toronto, Peel, Simcoe, Muskoka, Durham) that will help us collect and process valuable information on ACS patients and determine the benefits of different treatment options for STEMI patients. We have already obtained the approval of Sunnybrook Health Sciences Centre Research Ethics Board and acquired the support of Ontario Base Hospital Group Medical Advisory Committee and Executive Committee for PREDICT study.
This study will be implemented in collaboration with Program for Assessment of Technology in Health (PATH), St. Joseph’s Healthcare Hamilton
2. Who is eligible for this study?
Patients who call 911 and are suspected by the paramedics to have ischemic chest pain for greater than 30 minutes but less than 6 hours; are ≥ 18 years and experience chest pain that fails to completely respond to nitrates as per standard provincial chest pain protocol. Exclusion criteria includes patient < 18 years of age.
3. Why bother doing this study?
Cardiovascular disease is responsible for the death of more Canadians than any other disease and ischemic heart diseases. Acute myocardial infarction (AMI) accounts for a large proportion of these deaths. Reperfusion (intravenous fibrinolysis or percutaneous coronary interventions (PCI)) reduces mortality in patients suffering from acute ST segment elevation myocardial infarction (STEMI). Many studies have established that the earlier reperfusion therapy is delivered the greater the mortality reduction. Recent studies in Ontario have documented that most STEMI patients in Ontario still do not receive reperfusion therapy within established target times of <30 minutes for fibrinolysis or <90 minutes for PCI.
Studies of prehospital 12 lead electrocardiograms (PHECG) with advance Emergency Department (ED) notification suggest that there is a time to treatment advantage with this intervention since it reduces time delays. However these studies were all small, largely urban trials, and were carried out with advanced care paramedics, which may limit their generalizability to the Ontario rural and northern settings. In Ontario, many EMS systems cover large rural regions, and are frequently staffed by primary care paramedics with only basic life support training. Therefore, the benefits of PHECG in these settings are unclear.
In Ontario, the use of pre-hospital 12 lead ECG is not currently universal throughout the province with several regions/counties not currently considering the change in technology based on several factors, while other areas are in the planning stages. The regional differences between mixed rural/urban counties regarding the ability to have PHECG, as well as differences in the probability of bypass to a PCI centre present an opportunity to examine various scenarios for the pre-hospital management/routing of STEMI patients in Ontario and to compare both clinical and economic outcomes.
Some regions/hospitals in Ontario have already implemented PHECG and/or have developed bypass protocols (e.g. Toronto, Ottawa) and as such conducting a province wide randomized clinical trial in which patients will be randomized to PHECG or to a control group is not feasible. In addition, the diversity of Ontario in terms of rural/urban areas and access to services limits the generalizability of an evaluation of PHECG throughout Ontario, as the services in the major population centers are quite different then found in the more rural areas of the province (i.e. access to 12 lead ECG, ability to bypass to a PCI centre).
A comparative parallel prospective cohort study comparing PHECG with advance ED notification in mixed rural/urban areas with 12 lead ECG versus areas with only 3-lead ECG monitoring could provide evidence as to the potential benefit of implementing PHECG with a goal of reducing door to reperfusion times in patients with STEMI in these mixed urban/rural areas. In addition, results could provide insightful information for the implementations of PHECG in other regions of Ontario that currently do not have 12 lead ECG capabilities.
4. Who is involved?
This study will be conducted in a large region of Ontario including Muskoka/Simcoe, Haldimand-Norfolk, Brant, Niagara Region, Sudbury, Algoma
District, Thunder Bay, Essex, and Grey Bruce Huron counties. These regions comprise 2,134,300 people and represent 17% of the population of Ontario and 6.4% of the population of Canada. This geographic region covers 181426 km2 with variable population densities from 2.5 to 234 persons per km2 representing rural, suburban, urban, and metropolis areas. A total of 13 EMS operators function in this region, under the control of 8 EMS Base Hospital programs. Each regional EMS system is associated with a base hospital and a medical director responsible for medical oversight.
5. How will we measure the difference?
As primary outcome time from arrival to the ED to initiation of the reperfusion therapy will be compared between those receiving 12 lead PHECG and those receiving 3 lead ECG monitoring prior to hospital arrival. Different secondary outcomes such as survival at 30 days and one year as well as different time intervals, adjuvant therapies, ECG interpretation and economic evaluation will be compared between above mentioned groups of patients.
Data guardians will screen and identify all eligible cases from the routine collection of ACRS, then abstract the information from the ACR and collate with dispatch data and enter the data on the WEB based database. The data guardian just needs access to the internet. Inhospital data guardians will retrieve the inhospital data on a case report form and enter this on the WEB based database.
6. What are the timelines?
The objective is to collect data on total of 400 patients who meet the inclusion criteria and we project that this will take approximately 1.25 years. Approval for the study from the MOHLTC basehospital advisory group, and the research ethics boards of the base hospital affiliated institutions and all receiving hospitals will be acquired prior to implementation of this study. We would like to start collecting data as soon as we have REB approval at each site.