The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 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
Efforts to identify individuals at a higher risk for adverse cardiovascular outcomes focus on traditional risk factors, such as age, gender, smoking status, blood pressure, and cholesterol; however, this approach does not directly assess cardiovascular function and underestimates the risk of experiencing adverse cardiovascular outcomes in women. This prospective, observational trial will examine the ability of the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease screening protocol, a series of non-invasive procedures to identify middle-aged and older women who are at elevated risk for experiencing an adverse cardiovascular event in the five-year period after screening. The predictive value of the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol will also be compared to the Framingham Risk Score to determine if one method has better sensitivity for estimating risk for an adverse cardiovascular outcome.
详细描述
Every seven minutes in Canada, there is a death due to heart disease or stroke. Up to 80% of cardiovascular disease (CVD) could be prevented by identifying and controlling for biological risk factors such as hypertension, high cholesterol, and diabetes, and behavioral risk factors such as physical inactivity, unhealthy diet, and smoking. Efforts to identify individuals at a higher risk for adverse cardiovascular events, such as the Framingham Disease Risk (FDR) score, focus on traditional risk factors, such as age, gender, smoking status, blood pressure, and cholesterol. While this approach does estimate 10-year risk for heart attacks,3 it remains suboptimal as it does not assess how well each individual's cardiovascular system is functioning. In fact, a previous study suggests that more than 80% of females evaluated with the FDR were identified as being at low risk, or not qualifying for medications known to lower cardiovascular risk before experiencing a myocardial infarction. Therefore, these data warrant the use of cardiovascular screening approaches that are more accurate in identifying the risk of adverse cardiovascular outcomes.
There is a common perception that CVD is a 'man's disease'; however, women tend to develop heart disease approximately 10-15 years later than men, with a prevalence rate similar between sexes after ≥ 60 years of age. Heart disease is the leading cause of death in women worldwide. Women are often under-represented in cardiovascular clinical trials, which is an issue because their clinical presentation and prognosis of cardiovascular disease differs from that of men. In fact, women who suffer an acute MI are more likely to die, have an increased risk of repeat MI, develop heart failure, or consequentially suffer sudden cardiac death, as compared to men. Although improvements in CVD management have led to decreased mortality rates, more women than men have died from causes related to CVD since 1980. It is also important to highlight that traditional risk factors assessed by FDR score underestimate the risk of experiencing an adverse cardiovascular event in women, as compared to men. Thus, it appears that there is a need to develop innovative screening tools to better detect early stages of CVD risk amongst women.
The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease trial is a screening program designed to screen for cardiovascular risk in women. It was adapted from the 4-Test Rasmussen cardiovascular screening program, which was developed by Dr. Jay Cohn at the Center for Cardiovascular Disease Prevention, University of Minnesota. The 4-test screening approach utilizes non-invasive procedures to measure structural and functional changes in the large and small arteries, including elasticity of artery walls and blood pressure at rest and in response to 3-min of moderate intensity exercise. Tests are scored from 0-2 (0 = normal; 1 = borderline; 2 = abnormal) with a total RDS ranging from 0-8. Each participant is categorized based on risk (i.e. 0-2 = normal; 3-8 = abnormal). These simple, non-invasive procedures aim to detect early stages of CVD for individual asymptomatic patients. However, these tests are not yet available in the primary care setting and have not been used in a Canadian clinical context. Moreover, it is not known if this screening approach and other protocols are feasible and have sufficient predictive value within the context of the Canadian health care system, where health services in Canada are generally delivered by the private sector but funded by payments from provincial health insurance. The more comprehensive 10-test Rasmussen Disease Score (RDS), which uses, in addition to the 4-test approach, optic fundus imaging, a resting electrocardiogram, an ultrasound of the left ventricle and abdominal aorta, microalbumin, and brain natriuretic peptide, is better than the FDR at identifying individuals at risk for experiencing adverse cardiovascular events within 3-5 years.10 However, it is unknown whether the 4-test RDS (which will hereon in be referred to the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol) is a better predictor of future cardiac events than the FDR in women. It is also unknown if the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease screening protocol can predict future adverse cardiovascular events in women.
This prospective, observational study aims to: 1) determine if the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease screening protocol identifies middle-aged and older women who are at an elevated risk for experiencing adverse cardiovascular outcomes within a five-year period after screening; and, 2) compare the sensitivity and specificity value of the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol and the FDR for predicting future adverse cardiovascular outcomes in women. The investigators hypothesize that the Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease protocol will provide better diagnostic accuracy in identifying middle-aged and older women at an elevated risk for experiencing adverse cardiovascular outcomes in the five year period post-screening, as compared to the FDR.
The Assessment of Large and Small Artery Elasticity for the Early Detection of Cardiovascular Disease Protocol:
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
- 是
入选标准
- •women aged 55 and older
- •possess a Manitoba Personal Health Information Number
排除标准
- •previous hospitalization for:
- •ischemic heart disease
- •acute myocardial infarction
- •percutaneous coronary intervention
- •coronary artery bypass surgery
- •congestive heart failure
- •peripheral artery disease
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 participants recruited under the current protocol to determine if our 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 participants recruited under the current protocol to determine if our 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 participants recruited under the current protocol to determine if our 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 participants recruited under the current protocol to determine if our 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 participants recruited under the current protocol to determine if our 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 participants recruited under the current protocol to determine if our cardiovascular screening approach predicted which individuals were at moderate to high risk of an adverse cardiovascular outcome over the five-year period after screening.
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 participants recruited under the current protocol to determine if our 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