Key result
The WARM Hearts study is a prospective cohort protocol designed to evaluate whether novel non-invasive assessments and biomarkers improve the prediction of 5-year cardiovascular risk in 1000 women.
Why the study?
CVD is a leading cause of death in women, and novel approaches are needed to enhance traditional risk assessment and improve early identification of elevated CVD risk.
Do novel non-invasive assessments and biomarkers improve the identification of elevated risk for adverse cardiovascular events compared to the Framingham Risk Score in women aged 55 years or older?
Cohort (n=1,000)
Do novel non-invasive assessments and biomarkers improve the identification of elevated risk for adverse cardiovascular events compared to the Framingham Risk Score in women aged 55 years or older?
The WARM Hearts study protocol outlines a prospective cohort study to evaluate whether novel non-invasive assessments and biomarkers can improve cardiovascular risk prediction in women over 55 compared to the Framingham Risk Score.
Protocol for prospective cohort in women ≥55; leaves open whether novel assessments improve 5-year CV risk prediction over Framingham.
INTRODUCTION: Cardiovascular disease (CVD) is a leading cause of death in women. Novel approaches to detect early signs of elevated CVD risk in women are needed. Enhancement of traditional CVD risk assessment approaches through the addition of procedures to assess physical function or frailty as well as novel biomarkers of cardiovascular, gut and muscle health could improve early identification. The Women's Advanced Risk-assessment in Manitoba (WARM) Hearts study will examine the use of novel non-invasive assessments and biomarkers to identify women who are at elevated risk for adverse cardiovascular events. METHODS AND ANALYSIS: One thousand women 55 years of age or older will be recruited and screened by the WARM Hearts observational, cohort study. The two screening appointments will include assessments of medical history, gender variables, body composition, cognition, frailty status, functional fitness, physical activity levels, nutritional status, quality of life questionnaires, sleep behaviour, resting blood pressure (BP), BP response to moderate-intensity exercise, a non-invasive measure of arterial stiffness and heart rate variability. Blood sample analysis will be used to assess lipid and novel biomarker profiles and stool samples will support the characterisation of gut microbiota. The incidence of the adverse cardiovascular outcomes will be assessed 5 years after screening to compare WARM Hearts approaches to the Framingham Risk Score, the current clinical standard of assessing CVD risk in Canada. ETHICS AND DISSEMINATION: The University of Manitoba Health Research Ethics Board (7 October 2019) and the St Boniface Hospital Research Review Committee (7 October 2019) approved the trial (Ethics Number HS22576 (H2019:063)). Recruitment started 10 October 2020. Data gathered from the WARM Hearts study will be published in peer-reviewed journals and presented at national and international conferences. Knowledge translation strategies will be created to share our findings with stakeholders who are positioned to implement evidence-informed CVD risk assessment programming. TRIAL REGISTRATION NUMBER: NCT03938155.
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Rose et al. (2021) conducted a cohort in Cardiovascular disease risk (n=1,000). Novel non-invasive assessments and biomarkers vs. Framingham Risk Score was evaluated on Incidence of adverse cardiovascular outcomes. The WARM Hearts study is a prospective cohort protocol designed to evaluate whether novel non-invasive assessments and biomarkers improve the prediction of 5-year cardiovascular risk in 1000 women.
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