Myocardial Infarction Genes (MI-GENES) Study

Study Overview
=================
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.

Official Title
-----------------
Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack

Conditions
-----------------
Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication

Intervention / Treatment
-----------------
* Other: Genetic Risk Score


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Framingham Risk Score<br>Patients in this arm will receive their Framingham Risk Score of having a heart attack. | |
| Active Comparator: Framingham and Genetic Risk Score<br>Patients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack. | Other: Genetic Risk Score<br>* Patients in this arm will receive their genetic-informed risk for having a heart attack.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum LDL-cholesterol level |  | at 6 months post disclosure of CAD risk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Waist circumference |  | at 6 months post disclosure of CAD risk | 
| 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 | 
| Reaction to test results information (assessed by survey) |  | Immediately after risk disclosure | 
| Perceived risk (assessed by survey) |  | Immediately after risk disclosure and 6 months afterwards | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification