Myocardial Infarction Genes (MI-GENES) Study

Mayo Clinic

Status: Completed

Conditions: Coronary Artery Disease; Genomic Risk Communication; Myocardial Infarction

Treatments: Other: Genetic Risk Score

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01936675

U01HG006379 (U.S. NIH Grant/Contract)

12-001727

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Framingham Risk Score

No Intervention group

Description:

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

Framingham and Genetic Risk Score

Active Comparator group

Description:

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

Treatment:

Other: Genetic Risk Score