This study is being done to better understand how genetic information might improve assessment of heart attack risk.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
216
Patients in this arm will receive their genetic-informed risk for having a heart attack.
Mayo Clinic
Rochester, Minnesota, United States
Change in serum LDL-cholesterol level
Time frame: at 6 months post disclosure of CAD risk
Change in HDL-cholesterol
Time frame: at 6 months post disclosure of CAD risk
Change in systolic blood pressure measurements
Time frame: at 6 months post disclosure of CAD risk
Change in fasting blood glucose measurements
Time frame: at 6 months post disclosure of CAD risk
Number of Subjects Who Initiated Treatment with Statin Medications
Time frame: at 6 months post disclosure of CAD risk
Number of Subjects Who Used the Patient Portal at One Year
Time frame: at 6 months post disclosure of CAD risk
Shared decision making (as assessed by survey)
Time frame: Immediately after risk disclosure
Physician visit satisfaction (as assessed by survey)
Time frame: Immediately after risk disclosure
Genetic counseling satisfaction and perceived personal control (as assessed by survey)
Time frame: Immediately after risk disclosure
Body mass index measurements
Time frame: at 6 months post disclosure of CAD risk
Waist circumference
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Time frame: at 6 months post disclosure of CAD risk
Blood pressure
Time frame: at 6 months post disclosure of CAD risk
Dietary fat intake (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Physical activity (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Smoking cessation
Time frame: at 6 months post disclosure of CAD risk
Anxiety (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Rating of test results information (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Understanding of genetic risk or family history risk (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Reaction to test results information (assessed by survey)
Time frame: Immediately after risk disclosure
Perceived risk (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Intention to change (assessed by survey)
Time frame: 3 months after risk disclosure
Recall and measure of locus control (assessed by survey)
Time frame: 3 months after risk disclosure
Motivation and perceptions (assessed by survey)
Time frame: 3 months after risk disclosure
Attitudes towards genome sequencing (assessed by survey)
Time frame: 3 and 6 months after risk disclosure
Impact of events scale (assessed by survey)
Time frame: 3 and 6 months after risk disclosure
Genetic knowledge (assessed by survey)
Time frame: at enrollment and 6 months after risk disclosure
Attitude toward genetic testing (assessed by survey)
Time frame: 6 months after risk disclosure
Decisional regret and treatment beliefs (assessed by survey)
Time frame: 6 months after risk disclosure
Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
Time frame: 3 and 6 months after risk disclosure