Myocardial Infarction Genes (MI-GENES) Study (MI-GENES)

May 2, 2016 updated by: Iftikhar J. Kullo, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HDL-cholesterol
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Change in systolic blood pressure measurements
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Change in fasting blood glucose measurements
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Number of Subjects Who Initiated Treatment with Statin Medications
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Number of Subjects Who Used the Patient Portal at One Year
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Shared decision making (as assessed by survey)
Time Frame: Immediately after risk disclosure
Immediately after risk disclosure
Physician visit satisfaction (as assessed by survey)
Time Frame: Immediately after risk disclosure
Immediately after risk disclosure
Genetic counseling satisfaction and perceived personal control (as assessed by survey)
Time Frame: Immediately after risk disclosure
Immediately after risk disclosure
Body mass index measurements
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Waist circumference
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Blood pressure
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Dietary fat intake (assessed by survey)
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Physical activity (assessed by survey)
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Smoking cessation
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Anxiety (assessed by survey)
Time Frame: at 6 months post disclosure of CAD risk
at 6 months post disclosure of CAD risk
Rating of test results information (assessed by survey)
Time Frame: Immediately after risk disclosure and 6 months afterwards
Immediately after risk disclosure and 6 months afterwards
Understanding of genetic risk or family history risk (assessed by survey)
Time Frame: Immediately after risk disclosure and 6 months afterwards
Immediately after risk disclosure and 6 months afterwards
Reaction to test results information (assessed by survey)
Time Frame: Immediately after risk disclosure
Immediately after risk disclosure
Perceived risk (assessed by survey)
Time Frame: Immediately after risk disclosure and 6 months afterwards
Immediately after risk disclosure and 6 months afterwards
Intention to change (assessed by survey)
Time Frame: 3 months after risk disclosure
3 months after risk disclosure
Recall and measure of locus control (assessed by survey)
Time Frame: 3 months after risk disclosure
3 months after risk disclosure
Motivation and perceptions (assessed by survey)
Time Frame: 3 months after risk disclosure
3 months after risk disclosure
Attitudes towards genome sequencing (assessed by survey)
Time Frame: 3 and 6 months after risk disclosure
3 and 6 months after risk disclosure
Impact of events scale (assessed by survey)
Time Frame: 3 and 6 months after risk disclosure
3 and 6 months after risk disclosure
Genetic knowledge (assessed by survey)
Time Frame: at enrollment and 6 months after risk disclosure
at enrollment and 6 months after risk disclosure
Attitude toward genetic testing (assessed by survey)
Time Frame: 6 months after risk disclosure
6 months after risk disclosure
Decisional regret and treatment beliefs (assessed by survey)
Time Frame: 6 months after risk disclosure
6 months after risk disclosure
Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
Time Frame: 3 and 6 months after risk disclosure
3 and 6 months after risk disclosure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Iftikhar Kullo, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001727
  • U01HG006379 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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