Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Change in serum LDL-cholesterol level
研究概览
简要总结
This study is being done to better understand how genetic information might improve assessment of heart attack risk.
详细描述
This study aims to randomize patients to 2 arms. The first arm will receive the conventional Framingham risk score for coronary heart disease while the intervention arm will receive the genetics-informed risk for coronary artery disease.
The investigators will assess baseline blood lipid levels and follow the 2 arms up to 6 months after randomization. Primary endpoint is change in LDL levels between the 2 arms. Secondary outcomes include blood pressure control, weight, smoking cessation, and other lifestyle modifications.
This trial will help us understand whether coronary artery disease risk derived from genetic information would have a significant impact on patients' perception of coronary artery disease risk and motivate healthy lifestyle modifications that reduce their long term risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 45-70 years
- •Patients who have participated in the Mayo Clinic Biobank or a previous research study at Mayo Clinic
- •Patients who live in Southeast Minnesota
排除标准
- •Taking statin or other lipid lowering medications
- •Patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions
结局指标
主要结局
Change in serum LDL-cholesterol level
时间窗: at 6 months post disclosure of CAD risk
次要结局
- Change in HDL-cholesterol(at 6 months post disclosure of CAD risk)
- Number of Subjects Who Used the Patient Portal at One Year(at 6 months post disclosure of CAD risk)
- Blood pressure(at 6 months post disclosure of CAD risk)
- Attitudes towards genome sequencing (assessed by survey)(3 and 6 months after risk disclosure)
- Genetic knowledge (assessed by survey)(at enrollment and 6 months after risk disclosure)
- Change in systolic blood pressure measurements(at 6 months post disclosure of CAD risk)
- Change in fasting blood glucose measurements(at 6 months post disclosure of CAD risk)
- Waist circumference(at 6 months post disclosure of CAD risk)
- Anxiety (assessed by survey)(at 6 months post disclosure of CAD risk)
- Understanding of genetic risk or family history risk (assessed by survey)(Immediately after risk disclosure and 6 months afterwards)
- Impact of events scale (assessed by survey)(3 and 6 months after risk disclosure)
- Decisional regret and treatment beliefs (assessed by survey)(6 months after risk disclosure)
- Use of internet, electronic health record, social networks, and information sharing (assessed by survey)(3 and 6 months after risk disclosure)
- Number of Subjects Who Initiated Treatment with Statin Medications(at 6 months post disclosure of CAD risk)
- Genetic counseling satisfaction and perceived personal control (as assessed by survey)(Immediately after risk disclosure)
- Dietary fat intake (assessed by survey)(at 6 months post disclosure of CAD risk)
- Physical activity (assessed by survey)(at 6 months post disclosure of CAD risk)
- Smoking cessation(at 6 months post disclosure of CAD risk)
- Rating of test results information (assessed by survey)(Immediately after risk disclosure and 6 months afterwards)
- Attitude toward genetic testing (assessed by survey)(6 months after risk disclosure)
- Shared decision making (as assessed by survey)(Immediately after risk disclosure)
- Physician visit satisfaction (as assessed by survey)(Immediately after risk disclosure)
- Body mass index measurements(at 6 months post disclosure of CAD risk)
- Perceived risk (assessed by survey)(Immediately after risk disclosure and 6 months afterwards)
- Intention to change (assessed by survey)(3 months after risk disclosure)
- Motivation and perceptions (assessed by survey)(3 months after risk disclosure)
- Reaction to test results information (assessed by survey)(Immediately after risk disclosure)
- Recall and measure of locus control (assessed by survey)(3 months after risk disclosure)
研究者
Iftikhar J. Kullo
Professor of Medicine, Division of Cardiovascular Diseases, Department of Internal Medicine
Mayo Clinic