Myocardial Infarction Genes (MI-GENES) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Myocardial Infarction Genomic Risk Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Framingham Risk Score

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Genetic Risk Score

Intervention Type OTHER

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

Interventions

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Genetic Risk Score

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes