Myocardial Infarction Genes (MI-GENES) Study

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01936675

Collaborator

National Human Genome Research Institute (NHGRI) (NIH)

216

Enrollment

Location

Arms

Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to better understand how genetic information might improve assessment of heart attack risk.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Infarction Genomic Risk Communication	Other: Genetic Risk Score	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Framingham Risk Score Patients in this arm will receive their Framingham Risk Score of having a heart attack.
Active Comparator: Framingham and Genetic Risk Score 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 Patients in this arm will receive their genetic-informed risk for having a heart attack.

Arm

Intervention/Treatment

No Intervention: Framingham Risk Score

Patients in this arm will receive their Framingham Risk Score of having a heart attack.

Active Comparator: Framingham and Genetic Risk Score

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

Patients in this arm will receive their genetic-informed risk for having a heart attack.

Outcome Measures

Primary Outcome Measures

Change in serum LDL-cholesterol level [at 6 months post disclosure of CAD risk]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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