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

This study has been completed.
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Iftikhar J. Kullo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01936675
First received: September 3, 2013
Last updated: May 2, 2016
Last verified: May 2016
  Purpose
This study is being done to better understand how genetic information might improve assessment of heart attack risk.

Condition Intervention
Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Other: Genetic Risk Score

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in serum LDL-cholesterol level [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HDL-cholesterol [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure measurements [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose measurements [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Number of Subjects Who Initiated Treatment with Statin Medications [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Number of Subjects Who Used the Patient Portal at One Year [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Shared decision making (as assessed by survey) [ Time Frame: Immediately after risk disclosure ] [ Designated as safety issue: No ]
  • Physician visit satisfaction (as assessed by survey) [ Time Frame: Immediately after risk disclosure ] [ Designated as safety issue: No ]
  • Genetic counseling satisfaction and perceived personal control (as assessed by survey) [ Time Frame: Immediately after risk disclosure ] [ Designated as safety issue: No ]
  • Body mass index measurements [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Dietary fat intake (assessed by survey) [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Physical activity (assessed by survey) [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Smoking cessation [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Anxiety (assessed by survey) [ Time Frame: at 6 months post disclosure of CAD risk ] [ Designated as safety issue: No ]
  • Rating of test results information (assessed by survey) [ Time Frame: Immediately after risk disclosure and 6 months afterwards ] [ Designated as safety issue: No ]
  • Understanding of genetic risk or family history risk (assessed by survey) [ Time Frame: Immediately after risk disclosure and 6 months afterwards ] [ Designated as safety issue: No ]
  • Reaction to test results information (assessed by survey) [ Time Frame: Immediately after risk disclosure ] [ Designated as safety issue: No ]
  • Perceived risk (assessed by survey) [ Time Frame: Immediately after risk disclosure and 6 months afterwards ] [ Designated as safety issue: No ]
  • Intention to change (assessed by survey) [ Time Frame: 3 months after risk disclosure ] [ Designated as safety issue: No ]
  • Recall and measure of locus control (assessed by survey) [ Time Frame: 3 months after risk disclosure ] [ Designated as safety issue: No ]
  • Motivation and perceptions (assessed by survey) [ Time Frame: 3 months after risk disclosure ] [ Designated as safety issue: No ]
  • Attitudes towards genome sequencing (assessed by survey) [ Time Frame: 3 and 6 months after risk disclosure ] [ Designated as safety issue: No ]
  • Impact of events scale (assessed by survey) [ Time Frame: 3 and 6 months after risk disclosure ] [ Designated as safety issue: No ]
  • Genetic knowledge (assessed by survey) [ Time Frame: at enrollment and 6 months after risk disclosure ] [ Designated as safety issue: No ]
  • Attitude toward genetic testing (assessed by survey) [ Time Frame: 6 months after risk disclosure ] [ Designated as safety issue: No ]
  • Decisional regret and treatment beliefs (assessed by survey) [ Time Frame: 6 months after risk disclosure ] [ Designated as safety issue: No ]
  • Use of internet, electronic health record, social networks, and information sharing (assessed by survey) [ Time Frame: 3 and 6 months after risk disclosure ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: July 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936675

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Iftikhar Kullo, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Iftikhar J. Kullo, Professor of Medicine, Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01936675     History of Changes
Other Study ID Numbers: 12-001727  U01HG006379 
Study First Received: September 3, 2013
Last Updated: May 2, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Risk Stratification

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016