Myocardial Infarction Genes (MI-GENES) Study

Not Applicable

Completed

• Conditions: Genomic Risk Communication; Coronary Artery Disease; Myocardial Infarction
• Interventions: Other: Genetic Risk Score

• Registration Number: NCT01936675
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Framingham and Genetic Risk Score	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.

Primary Outcome Measures

Name	Time	Method
Change in serum LDL-cholesterol level	at 6 months post disclosure of CAD risk

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States