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Completed

NCT Number: NCT01936675

Myocardial Infarction Genes (MI-GENES) Study

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Genomic Risk Communication Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic Risk Score

Other

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

Primary outcomes

  1. Change in serum LDL-cholesterol level

    Time frame: at 6 months post disclosure of CAD risk

Secondary outcomes

  1. Change in HDL-cholesterol

    Time frame: at 6 months post disclosure of CAD risk

  2. Change in systolic blood pressure measurements

    Time frame: at 6 months post disclosure of CAD risk

  3. Change in fasting blood glucose measurements

    Time frame: at 6 months post disclosure of CAD risk

  4. Number of Subjects Who Initiated Treatment with Statin Medications

    Time frame: at 6 months post disclosure of CAD risk

  5. Number of Subjects Who Used the Patient Portal at One Year

    Time frame: at 6 months post disclosure of CAD risk

  6. Shared decision making (as assessed by survey)

    Time frame: Immediately after risk disclosure

  7. Physician visit satisfaction (as assessed by survey)

    Time frame: Immediately after risk disclosure

  8. Genetic counseling satisfaction and perceived personal control (as assessed by survey)

    Time frame: Immediately after risk disclosure

  9. Body mass index measurements

    Time frame: at 6 months post disclosure of CAD risk

  10. Waist circumference

    Time frame: at 6 months post disclosure of CAD risk

  11. Blood pressure

    Time frame: at 6 months post disclosure of CAD risk

  12. Dietary fat intake (assessed by survey)

    Time frame: at 6 months post disclosure of CAD risk

  13. Physical activity (assessed by survey)

    Time frame: at 6 months post disclosure of CAD risk

  14. Smoking cessation

    Time frame: at 6 months post disclosure of CAD risk

  15. Anxiety (assessed by survey)

    Time frame: at 6 months post disclosure of CAD risk

  16. Rating of test results information (assessed by survey)

    Time frame: Immediately after risk disclosure and 6 months afterwards

  17. Understanding of genetic risk or family history risk (assessed by survey)

    Time frame: Immediately after risk disclosure and 6 months afterwards

  18. Reaction to test results information (assessed by survey)

    Time frame: Immediately after risk disclosure

  19. Perceived risk (assessed by survey)

    Time frame: Immediately after risk disclosure and 6 months afterwards

  20. Intention to change (assessed by survey)

    Time frame: 3 months after risk disclosure

  21. Recall and measure of locus control (assessed by survey)

    Time frame: 3 months after risk disclosure

  22. Motivation and perceptions (assessed by survey)

    Time frame: 3 months after risk disclosure

  23. Attitudes towards genome sequencing (assessed by survey)

    Time frame: 3 and 6 months after risk disclosure

  24. Impact of events scale (assessed by survey)

    Time frame: 3 and 6 months after risk disclosure

  25. Genetic knowledge (assessed by survey)

    Time frame: at enrollment and 6 months after risk disclosure

  26. Attitude toward genetic testing (assessed by survey)

    Time frame: 6 months after risk disclosure

  27. Decisional regret and treatment beliefs (assessed by survey)

    Time frame: 6 months after risk disclosure

  28. Use of internet, electronic health record, social networks, and information sharing (assessed by survey)

    Time frame: 3 and 6 months after risk disclosure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)

Registry information

Official study title

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

Acronym: MI-GENES

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2013
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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