CIHR and industry sponsored study to use HeartCheck™ PEN and ECG monitors to screen 8,000 people through in-pharmacy and primary care physician offices for stroke risk
Toronto, Canada – CardioComm Solutions, Inc. (TSX-V:EKG) (“CardioComm Solutions” or the “Company”), a global medical provider of electrocardiogram (“ECG”) acquisition and management software solutions, announced it is working with the Canadian Atrial Fibrillation Stroke Prevention Intervention Network (“CSPIN”) as the ECG screening solutions provider for their research study entitled, “Program for the Identification of ‘Actionable’ Atrial Fibrillation (‘PIAAF’): Systematic Screening to Detect Previously Undiagnosed or Untreated AF in the Community”.
The aim of PIAAF is to determine the most cost-effective methods and settings to screen 8,000 individuals, aged 65 years and older, to identify Atrial Fibrillation (“AF”) and determine who would benefit from oral anticoagulation therapy. PIAAF will obtain data to guide the design of a larger Canadian, cluster-randomized, controlled trial whose ultimate goal is to prevent stroke by improving early detection and treatment AF. PIAFF study objectives are: (1) to compare the feasibility and rate of AF detection with one-time measures using a manual pulse check vs. an automated blood pressure device with a validated AF-detection system vs. CardioComm Solutions’ handheld HeartCheck™ ECG monitor, and in a sub-group of up to 150 patients the HeartCheck™ PEN ECG device will be compared against the sensitivity of a 14-day external ECG loop event recorder for AF capture/detection; (2) to compare the feasibility and rate of AF detection using these technologies in primary care practices, community pharmacies, and patients’ homes; and (3) to determine the cost of screening per case of actionable AF detected.
“The Program to Identify Actionable Atrial Fibrillation (PIAAF) will take place in at least 25 rural and urban family practices and 20 pharmacies in Ontario, Quebec, British Columbia, Alberta and Nova Scotia. Based on prior pilot work, we estimated that 8,000 patients can be enrolled within 3 months with recruitment beginning in 2014. PIAAF will be funded by the Canadian Stroke Prevention Intervention Network, which in turn has received support from the Canadian Institutes of Health Research (CIHR); the Government of Canada’s health research investment agency. Confirmation that the project will receive their support speaks to the importance of performing this research.” stated Dr. Jeff Healey, principal investigator and Director of Arrhythmia Services, Hamilton Health Sciences, Associate Professor, Population Health Research Institute, McMaster University. “The results of the PIAAF study will be used for the design of a large-scale screening and intervention, cluster randomized trial. We anticipate this work will lead to the creation of the Canadian national practice guidelines for AF screening in primary care, and will have immediate implications for enhancing primary and secondary stroke prevention worldwide.”
“We are very pleased to have been selected to participate in this important project. The opportunity to support this research study with guidance from academic key opinion leaders drawn from the McMaster University Population Health Research Institute, Sunnybrook Health Science Centre (University of Toronto), Women’s College Hospital (University of Toronto), the University of Calgary Libin Cardiovascular Institute of Alberta and the University of Alberta will ensure an unbiased and rigorous application of our technologies. CardioComm Solutions will derive financial benefit from this project while still offering in-kind support to CSPIN to offset operational expenses, a requirement for participation in such an academic program,” said Etienne Grima, CEO of CardioComm Solutions.
“CardioComm Solutions is continuing its efforts to expand the use of the HeartCheck™ and SMART Monitoring technologies through large scale and individual ECG screening efforts. We have placed specific attention on the detection of AF for the prevention of stroke and the targeting of related academic research opportunities. To further support this. CardioComm Solutions will also be launching the ECG screening HeartCheckTM Partner Program. This Partner Program initiative will involve long term care facility operators, pharmacy channels and health fitness providers and will be an important part of our strategy to drive HeartCheck™ PEN sales and SMART Monitoring ECG services,” said Mr. Simi Grosman, member of the Board of Directors of the Company.
About Canadian Atrial Fibrillation Stroke Prevention Intervention Network (CSPIN)
CSPIN is an organization comprised of a multi-disciplinary team of cardiologists, neurologists, cardiac surgeons, emergency room physicians, family practitioners, pharmacists, statisticians, methodologists, knowledge translation experts and population scientists. CSPIN’s goal is to make Canada a global leader in clinical stroke research and in collaboration with government and stakeholder groups, implement strategies to reduce the incidence of embolic stroke in Canada by 10% within 10 years. The initial phase of the CSPIN collaboration will involve the design and initiation of seven randomized clinical trials aimed at embolic stroke prevention, particularly those due to AF.