Dataset Information

Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a prospective, observational cohort study.

ABSTRACT:

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.

SUBMITTER: Rose AV

PROVIDER: S-EPMC8154968 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.

Project description:Neighborhood greenness has been linked to better cardiovascular health, but little is known about its association with biomarkers related to cardiovascular risk. Adverse neighborhood conditions, such as disorder and socioeconomic disadvantage, are associated with higher cardiovascular biomarker levels, but these relationships may differ in neighborhoods with more greenness. This study evaluated cross-sectional associations of validated measures of neighborhood greenness, disorder, and socioeconomic disadvantage with cardiovascular biomarkers in middle-aged and older adults living in Baltimore City. The sample included 500 adults, aged 57-79 years, enrolled in the Baltimore Memory Study and living in Baltimore City during 2009-2010. Multi-level log-gamma regressions examined associations between the three neighborhood characteristics and seven cardiovascular biomarkers. Models additionally evaluated the effect modification by neighborhood greenness on associations of neighborhood disorder and socioeconomic disadvantage with the biomarkers. Adjusting for covariates and neighborhood greenness, greater neighborhood disorder was associated with higher C-reactive protein (exp β = 1.21, SE = 0.11, p = 0.035) and serum amyloid A (exp β = 1.28, SE = 0.12, p = 0.008), while greater neighborhood socioeconomic disadvantage was associated with higher tumor necrosis factor alpha (exp β = 1.24, SE = 0.12, p = 0.019). Higher neighborhood greenness was associated with lower soluble vascular cell adhesion molecule-1, accounting for disorder (exp β = 0.70, SE = 0.10, p = 0.010) and socioeconomic disadvantage (exp β = 0.73, SE = 0.10, p = 0.025). There was no evidence of effect modification among neighborhood characteristics. The findings suggest that neighborhood effects on cardiovascular health may be mediated through cardiovascular biomarker levels, and that socioeconomic disadvantage, disorder, and greenness may each be important features of neighborhoods.

Project description:BackgroundPrediabetes progression is associated with increased mortality while its regression decreases it. It is unclear whether muscle strength is related to prediabetes progression or regression. This study investigated the associations of muscle strength, assessed by grip strength and chair-rising time, with prediabetes progression and regression based on the China Health and Retirement Longitudinal Study (CHARLS) enrolling middle-aged and older adults.MethodsWe included 2623 participants with prediabetes from CHARLS, who were followed up 4 years later with blood samples collected for measuring fasting plasma glucose and haemoglobin A1c. Grip strength (normalized by body weight) and chair-rising time were assessed at baseline and categorized into tertiles (low, middle, and high groups). Prediabetes at baseline and follow-up was defined primarily using the American Diabetes Association (ADA) criteria and secondarily using the World Health Organization (WHO) and International Expert Committee (IEC) criteria. Multinomial logistic regression analysis was applied to obtain the odds ratios (ORs) and 95% confidence intervals (CIs).ResultsThe mean age of included participants was 59.0 ± 8.6 years, and 46.6% of them were males. During follow-up, 1646 participants remained as prediabetes, 379 progressed to diabetes, and 598 regressed to normoglycaemia based on ADA criteria. Participants who progressed to diabetes had lower normalized grip strength than those who remained as prediabetes (0.49 ± 0.15 vs. 0.53 ± 0.15, P < 0.001), but participants who regressed to normoglycaemia showed the opposite (0.55 ± 0.16 vs. 0.53 ± 0.15, P = 0.003). However, chair-rising time was comparable across different groups (Poverall = 0.17). Compared with participants in low normalized grip strength or high chair-rising time group, those in high normalized grip strength or low chair-rising time group had decreased odds of progression to diabetes (OR 0.62, 95% CI 0.44 to 0.87; and OR 0.69, 95% CI 0.51 to 0.93, respectively) after multivariable adjustment. However, both were unrelated to the odds of regression to normoglycaemia (OR 0.94, 95% CI 0.71 to 1.25; and OR 0.84, 95% CI 0.65 to 1.07, respectively). These outcomes remained generally comparable when prediabetes was defined by WHO or IEC criteria. Higher normalized grip strength but not lower chair-rising time was prospectively associated with lower blood pressure, better glycaemic condition, and lower inflammation (all P ≤ 0.04).ConclusionsHigh muscle strength is associated with reduced odds of progression to diabetes but does not predict regression to normoglycaemia in prediabetes. Future studies are warranted to assess whether increases in muscle strength promote prediabetes regression.