Coronary Artery Disease, Genomic Risk Communication, Myocardial Infarction
Conditions
Keywords
Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification
Brief summary
This study is being done to better understand how genetic information might improve assessment of heart attack risk.
Detailed description
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.
Interventions
OTHERGenetic Risk Score
Patients in this arm will receive their genetic-informed risk for having a heart attack.
Sponsors
National Human Genome Research Institute (NHGRI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Taking statin or other lipid lowering medications * Patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum LDL-cholesterol level | at 6 months post disclosure of CAD risk |
Secondary
| Measure | Time frame |
|---|---|
| Intention to change (assessed by survey) | 3 months after risk disclosure |
| Recall and measure of locus control (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 |
| Change in HDL-cholesterol | at 6 months post disclosure of CAD risk |
| 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 |
| Number of Subjects Who Initiated Treatment with Statin Medications | 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 |
| Shared decision making (as assessed by survey) | Immediately after risk disclosure |
| Physician visit satisfaction (as assessed by survey) | Immediately after risk disclosure |
| Genetic counseling satisfaction and perceived personal control (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 |
| Blood pressure | at 6 months post disclosure of CAD risk |
| 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 |
| Anxiety (assessed by survey) | at 6 months post disclosure of CAD risk |
| Rating of test results information (assessed by survey) | Immediately after risk disclosure and 6 months afterwards |
| Understanding of genetic risk or family history risk (assessed by survey) | Immediately after risk disclosure and 6 months afterwards |
| Attitudes towards genome sequencing (assessed by survey) | 3 and 6 months after risk disclosure |
| Impact of events scale (assessed by survey) | 3 and 6 months after risk disclosure |
| Genetic knowledge (assessed by survey) | at enrollment and 6 months after risk disclosure |
| Attitude toward genetic testing (assessed by survey) | 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 |
| Waist circumference | at 6 months post disclosure of CAD risk |
Countries
United States
Outcome results
None listed