Myocardial Infarction Genes (MI-GENES) Study

Coronary Artery Disease Clinical Trial

— MI-GENES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936675
• Other study ID #: 12-001727
• Secondary ID: U01HG006379
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: May 2, 2016
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Genomic Risk Communication
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Genetic Risk Score
Patients in this arm will receive their genetic-informed risk for having a heart attack.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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 — View 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 — View 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 — View Citation

Outcome

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