Myocardial Infarction Genes (MI-GENES) Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Iftikhar J. Kullo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01936675
First received: September 3, 2013
Last updated: May 27, 2014
Last verified: May 2014

September 3, 2013
May 27, 2014
July 2013
July 2015   (final data collection date for primary outcome measure)
Change in LDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01936675 on ClinicalTrials.gov Archive Site
  • Change in HDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
  • Change in fasting blood sugar [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Myocardial Infarction Genes (MI-GENES) Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Coronary Artery Disease
  • Myocardial Infarction
  • Genomic Risk Communication
Other: Genetic Risk Score
Patients in this arm will receive their genetic-informed risk for having a heart attack.
  • 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.
    Intervention: Other: Genetic Risk Score
Ding K, Bailey KR, Kullo IJ. Genotype-informed estimation of risk of coronary heart disease based on genome-wide association data linked to the electronic medical record. BMC Cardiovasc Disord. 2011 Nov 3;11:66. doi: 10.1186/1471-2261-11-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
January 2016
July 2015   (final data collection date for primary outcome measure)

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
Both
45 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01936675
12-001727, U01HG006379
No
Iftikhar J. Kullo, Mayo Clinic
Mayo Clinic
National Human Genome Research Institute (NHGRI)
Principal Investigator: Iftikhar Kullo, MD Mayo Clinic
Mayo Clinic
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP