Women's Advanced Risk-assessment in Manitoba (WARM) Hearts - Examining Cardiovascular Disease Risk in Middle Aged and Older Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Ischemic heart disease
研究概览
简要总结
The main objective of this study is to test the ability of novel cardiovascular disease (CVD) prognostic tools to identify women at risk for future CVD. We plan to establish a cardiovascular health screening program at the St. Boniface Hospital and to test the efficacy of these tests for predicting adverse cardiovascular outcomes amongst a cohort of 1000 Manitoban women aged 55 years and older in the 5-year period after screening.
A second purpose of this project is to identify novel CVD biomarkers that may indicate a person is at risk for cardiovascular disease. Therefore, we plan to ask participants for permission to collect and store a sample of both their blood and stool for future research.
详细描述
Women tend to develop heart disease approximately 10-15 years later than men, with a prevalence rate similar between sexes after women turn 55 years of age. Unfortunately, women have been under represented in cardiovascular disease (CVD) research, leading to the development of screening tools that are not able to adequately identify women at risk. Current methods of CVD risk in women in the clinical setting (Framingham Risk Score) underestimate this risk as compared to men. Thus, it appears that current screening tools are not sensitive to women's cardiovascular health, which may result in a missed diagnosis of CVD risk.
Efforts to prevent CVD focus on traditional risk factors (e.g. age, sex, smoking, cholesterol and blood pressure), which do estimate 10-year risk for heart attacks. However, this approach does not determine how well the cardiovascular system is functioning for individuals. A better approach may be the addition of non-invasive procedures to detect early stages of CVD for individual patients, which are not yet available in the primary care setting.
This project builds off of Dr. Duhamel's previous work looking at novel prognostic CVD testing in women, which successfully recruited 1030 women into "The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease trial (see ClinicalTrials.gov Identifier: NCT02863211)" trial in a 20 month period ending May 2017. Data from that research was presented at the 2018 Canadian Women's Heart Health Summit and identified that the addition of frailty assessments to health screening has the potential to identify women with elevated CVD risk. We are taking that knowledge forward and have developed this new trial to include additional frailty measurement approaches to determine if their addition further enhances CVD risk screening.
If this new research demonstrates that the proposed CVD risk screening approach is superior to the Framingham Risk Score (FRS) at identifying individuals who have early markers of cardiovascular disease, individuals with elevated CVD risk may be empowered to participate in interventions known to restore cardiovascular health.
Trial Objectives and Purpose
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 55 and older
- •possess a Manitoba Personal Health Information Number
排除标准
- •Previous hospitalization or treatment for:
- •Ischemic heart disease
- •Acute myocardial infarction
- •Stroke/Transient ischemic attack
- •Percutaneous coronary intervention
- •Coronary artery bypass surgery
- •Congestive heart failure
- •Peripheral artery disease
- •Congenital heart defects
- •Arrhythmia
- •Additional exclusion:
- •Medical advice against physical activity
- •Previous participant in the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease (NCT02863211)
结局指标
主要结局
Ischemic heart disease
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Acute myocardial infarction
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Stroke
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Transient ischemic attack
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Future diagnosis of hypertension
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Percutaneous coronary intervention
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Coronary artery bypass surgery
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
Congestive heart failure
时间窗: 5 years post-screening
Each individual's Personal Health Information Number (PHIN) will be utilized to follow the study participants and to determine if they experienced an adverse cardiovascular outcome using the Manitoba Centre for Health Policy (MCHP) Population Health Research Data Repository. Hospital separations abstracts, medical claims and the Drug Program Information Network will be examined to provide information on hospitalizations for cardiac diseases, cardiac procedures performed, cardiac-related and other medications used, and diagnoses with cardiac diseases. Vital statistics will also provide information on cause of death to allow for mortality rate tracking. This administrative health data will be used to compare adverse cardiovascular events with the WARM Hearts protocol results to determine if this cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
次要结局
未报告次要终点
研究者
Dr. Todd A Duhamel
Principal Investigator
St. Boniface Hospital