Clinical trial NCT01936675: Myocardial Infarction Genes (MI-GENES) Study
Official title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Keywords: Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Risk Stratification
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2013-09-06
Enrollment: 216
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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 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

Primary outcomes:
measure: Change in serum LDL-cholesterol level
timeFrame: at 6 months post disclosure of CAD risk
Secondary outcomes:
measure: Change in HDL-cholesterol
timeFrame: at 6 months post disclosure of CAD risk
measure: Change in systolic blood pressure measurements
timeFrame: at 6 months post disclosure of CAD risk
measure: Change in fasting blood glucose measurements
timeFrame: at 6 months post disclosure of CAD risk
measure: Number of Subjects Who Initiated Treatment with Statin Medications
timeFrame: at 6 months post disclosure of CAD risk
measure: Number of Subjects Who Used the Patient Portal at One Year
timeFrame: at 6 months post disclosure of CAD risk
measure: Shared decision making (as assessed by survey)
timeFrame: Immediately after risk disclosure
measure: Physician visit satisfaction (as assessed by survey)
timeFrame: Immediately after risk disclosure
measure: Genetic counseling satisfaction and perceived personal control (as assessed by survey)
timeFrame: Immediately after risk disclosure
measure: Body mass index measurements
timeFrame: at 6 months post disclosure of CAD risk
measure: Waist circumference
timeFrame: at 6 months post disclosure of CAD risk
measure: Blood pressure
timeFrame: at 6 months post disclosure of CAD risk
measure: Dietary fat intake (assessed by survey)
timeFrame: at 6 months post disclosure of CAD risk
measure: Physical activity (assessed by survey)
timeFrame: at 6 months post disclosure of CAD risk
measure: Smoking cessation
timeFrame: at 6 months post disclosure of CAD risk
measure: Anxiety (assessed by survey)
timeFrame: at 6 months post disclosure of CAD risk
measure: Rating of test results information (assessed by survey)
timeFrame: Immediately after risk disclosure and 6 months afterwards
measure: Understanding of genetic risk or family history risk (assessed by survey)
timeFrame: Immediately after risk disclosure and 6 months afterwards
measure: Reaction to test results information (assessed by survey)
timeFrame: Immediately after risk disclosure
measure: Perceived risk (assessed by survey)
timeFrame: Immediately after risk disclosure and 6 months afterwards
measure: Intention to change (assessed by survey)
timeFrame: 3 months after risk disclosure
measure: Recall and measure of locus control (assessed by survey)
timeFrame: 3 months after risk disclosure
measure: Motivation and perceptions (assessed by survey)
timeFrame: 3 months after risk disclosure
measure: Attitudes towards genome sequencing (assessed by survey)
timeFrame: 3 and 6 months after risk disclosure
measure: Impact of events scale (assessed by survey)
timeFrame: 3 and 6 months after risk disclosure
measure: Genetic knowledge (assessed by survey)
timeFrame: at enrollment and 6 months after risk disclosure
measure: Attitude toward genetic testing (assessed by survey)
timeFrame: 6 months after risk disclosure
measure: Decisional regret and treatment beliefs (assessed by survey)
timeFrame: 6 months after risk disclosure
measure: Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
timeFrame: 3 and 6 months after risk disclosure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Iftikhar Kullo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Robinson CL, Jouni H, Kruisselbrink TM, Austin EE, Christensen KD, Green RC, Kullo IJ. Disclosing genetic risk for coronary heart disease: effects on perceived personal control and genetic counseling satisfaction. Clin Genet. 2016 Feb;89(2):251-7. doi: 10.1111/cge.12577. Epub 2015 Mar 23.
citation: Kullo IJ, Jouni H, Olson JE, Montori VM, Bailey KR. Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study. BMC Med Genomics. 2015 Aug 15;8:51. doi: 10.1186/s12920-015-0122-0.
citation: Kullo IJ, Jouni H, Austin EE, Brown SA, Kruisselbrink TM, Isseh IN, Haddad RA, Marroush TS, Shameer K, Olson JE, Broeckel U, Green RC, Schaid DJ, Montori VM, Bailey KR. Incorporating a Genetic Risk Score Into Coronary Heart Disease Risk Estimates: Effect on Low-Density Lipoprotein Cholesterol Levels (the MI-GENES Clinical Trial). Circulation. 2016 Mar 22;133(12):1181-8. doi: 10.1161/CIRCULATIONAHA.115.020109. Epub 2016 Feb 25.
citation: Brown SN, Jouni H, Kullo IJ. Electronic health record access by patients as an indicator of information seeking and sharing for cardiovascular health promotion in social networks: Secondary analysis of a randomized clinical trial. Prev Med Rep. 2019 Jan 14;13:306-313. doi: 10.1016/j.pmedr.2018.12.011. eCollection 2019 Mar.
citation: Brown SN, Jouni H, Marroush TS, Kullo IJ. Effect of Disclosing Genetic Risk for Coronary Heart Disease on Information Seeking and Sharing: The MI-GENES Study (Myocardial Infarction Genes). Circ Cardiovasc Genet. 2017 Aug;10(4):e001613. doi: 10.1161/CIRCGENETICS.116.001613.
citation: Jouni H, Haddad RA, Marroush TS, Brown SA, Kruisselbrink TM, Austin EE, Shameer K, Behnken EM, Chaudhry R, Montori VM, Kullo IJ. Shared decision-making following disclosure of coronary heart disease genetic risk: results from a randomized clinical trial. J Investig Med. 2017 Mar;65(3):681-688. doi: 10.1136/jim-2016-000318. Epub 2016 Dec 19.