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  • 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

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Cardiovascular medicine
Protocol
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
  1. Kevin F Boreskie1,2,
  2. D Scott Kehler1,2,
  3. Eduardo C Costa2,3,
  4. Pedro C Cortez2,4,
  5. Ivan Berkowitz2,
  6. Naomi C Hamm1,2,
  7. Teri L Moffatt1,2,
  8. Andrew N Stammers1,2,
  9. Dustin E Kimber1,2,
  10. Brett M Hiebert5,
  11. David E Kent1,2,
  12. Denise E Cornish1,2,
  13. Heather Blewett6,7,
  14. Thang Nguyen8,
  15. Rakesh C Arora2,9,
  16. Shaelyn M Strachan1,
  17. Brittany N Semenchuk1,
  18. Jacqueline L Hay1,2,
  19. Jay N Cohn10,
  20. Todd A Duhamel1,2
  1. 1 Faculty of Kinesiology and Recreation Management, Health, Leisure & Human Performance Research Institute, University of Manitoba, Winnipeg, Manitoba, Canada
  2. 2 Institute of Cardiovascular Sciences, St. Boniface Hospital Albrechtsen Research Centre, Winnipeg, Manitoba, Canada
  3. 3 Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil
  4. 4 Federal University of Para, Para, Brazil
  5. 5 Department of Cardiac Sciences Program, Winnipeg Regional Health Authority, Winnipeg, Manitoba, Canada
  6. 6 Agriculture and Agri-Food Canada, Government of Canada, Winnipeg, Manitoba, Canada
  7. 7 Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
  8. 8 Section of Cardiology, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada
  9. 9 Department of Surgery, University of Manitoba, Max Rady College of Medicine, Winnipeg, Manitoba, Canada
  10. 10 Rasmussen Center for Cardiovascular Disease Prevention, University of Minnesota Medical School, Minneapolis, Minnesota, USA
  1. Correspondence to Dr Todd A Duhamel; tduhamel{at}sbrc.ca

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 classified 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).

Trial registration number NCT02863211.

  • adult cardiology
  • coronary heart disease
  • heart failure
  • hypertension
  • ischaemic heart disease
  • myocardial infarction

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-018249

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    Footnotes

    • Contributors TAD, DSK and IB were involved in conception and design of research. TAD and IB secured funding for the project. DSK, TAD and RCA obtained ethics approval. ECC prepared the figures. KFB, ECC, PCC, DSK and TAD drafted the manuscript. All authors edited and revised the manuscript. All authors approved the final version of the manuscript. KFB, ECC, PCC, DSK, NCH, TLM, ANS, DEK, JLH, BNS and DEC assisted with data collection and analysis. BH provided statistical support. KFB and DEK provided research administration support. HB assisted with blood sample analysis.

    • 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.

    • Competing interests The 4-Test Rasmussen cardiovascular screening program protocol is protected by intellectual property owned by the University of Minnesota and licensed to CVC-HEARTSAVERS LLC. St. Boniface General Hospital has a service agreement to utilize the methodology.

    • Ethics approval The study protocol V.3.0 has been reviewed by the University of Manitoba Health Research Ethics Board and has been approved V.3.0 (H2014:224) on August 15, 2016.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Data for the HAPPY Hearts study can be made available upon request. Interested researchers should contact Dr TAD at tduhamel@sbrc.ca.