BMJ open protocol for the HAPPY Hearts study: Cardiovascular screening for the early detection of future adverse cardiovascular outcomes in middle-aged and older women: A prospective, observational cohort study

Kevin F. Boreskie, D. Scott Kehler, Eduardo C. Costa, Pedro C. Cortez, Ivan Berkowitz, Naomi C. Hamm, Teri L. Moffatt, Andrew N. Stammers, Dustin E. Kimber, Brett M. Hiebert, David E. Kent, Denise E. Cornish, Heather Blewett, Thang Nguyen, Rakesh C. Arora, Shaelyn M. Strachan, Brittany N. Semenchuk, Jacqueline L. Hay, Jay N. Cohn, Todd A. Duhamel

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Abstract

Introduction Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus on traditional risk factors, such as age, sex, smoking status, blood pressure and and cholesterol; however, this approach does not directly assess cardiovascular function and may underestimate the risk of experiencing adverse cardiovascular outcomes in women. This prospective, observational cohort study will examine the ability of the Heart Attack Prevention Program for You (HAPPY) Hearts screening protocol, a series of non-invasive procedures to identify middle-aged and older women who are at an elevated risk for experiencing an adverse cardiovascular event in the 5-year period after screening. The predictive value of the HAPPY Hearts protocol will also be compared with the Framingham Risk Score to determine the sensitivity for estimating risk for an adverse cardiovascular outcome. Methods and analysis One thousand women 55 years of age or older will be recruited to be screened by the HAPPY Hearts protocol. This involves the cardiovascular assessment of resting blood pressure, blood pressure response to 3 min of moderate intensity exercise and large and small arterial elasticity. The participants will be classifed into risk categories based on these measures. The incidence of the following adverse cardiovascular outcomes will be assessed in the 5-year period after screening in both groups: ischaemic heart disease, acute myocardial infarction, stroke, percutaneous coronary intervention, coronary bypass surgery, congestive heart failure and new hypertension. Ethics and dissemination Information gathered in this research will be published in peer-reviewed journals and presented in a programme evaluation report to inform Manitoba Health and key stakeholders about the outcomes of the study. The University of Manitoba Health Research Ethics Board has approved the study protocol V.2.0, dated 29 September 2014 (H2014:224).

Original languageEnglish (US)
Article numbere018249
JournalBMJ open
Volume7
Issue number11
DOIs
StatePublished - 2017

Bibliographical note

Funding Information:
1Faculty of Kinesiology and Recreation Management, Health, Leisure & Human Performance Research Institute, University of Manitoba, Winnipeg, Manitoba, Canada 2Institute of Cardiovascular Sciences, St. Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada 3Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil 4Federal University of Para, Para, Brazil 5Department of Cardiac Sciences Program, Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada 6Agriculture and Agri-Food Canada, Government of Canada, Winnipeg, Manitoba, Canada 7Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada 8Section of Cardiology, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada 9Department of Surgery, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada 10Rasmussen Center for Cardiovascular Disease Prevention, University of Minnesota Medical School, Minneapolis, Minnesota, USA Acknowledgements The authors would like to acknowledge the infrastructure support provided by the St. Boniface Hospital Albrechtsen Research Centre and the I.H. Asper Clinical Research Institute. Operating funds to support this research was generously provided by the St. Boniface Hospital Research Foundation, the Canadian Pacific Railway and the Sir Thomas Cropo Foundation Inc. The authors would also like to thank Terry MacLeod on CBC Radio One, Chuck LaFleche and Greg Mackling on the CJOB Health Report, CKJS 810AM, the Filipino Express News Magazine and the Women’s Heart Health Forum at the Westminster United Church for their assistance in recruiting study participants.

Funding Information:
Funding The study is being financially supported by an operating grant from the St. Boniface Hospital Foundation. KFB is supported by a Manitoba Graduate Scholarship and the Graduate Enhancement of Tri-Council Stipends program. ECC is supported by the National Council for Scientific and Technological Development (CNPq; process 201422/2015-8). PCC is supported by the National Council for Scientific and Technological Development. DSK is supported by a Canadian Institutes of Health Research Frederick Banting and Charles Best Canada Graduate Scholarship. ANS is supported by a CIHR Frederick Banting and Charles Best Canada Graduate Scholarship, the Ruth Asper Scholarship in Physical Education, Kinesiology and Recreation and a University of Manitoba Jack MacDonnell Scholarship for Research in Aging. JLH and NCH are supported by the University of Manitoba Graduate Fellowship program.

Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017.

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