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| ID | Type | Description | Link |
|---|---|---|---|
| U01HG006379 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Framingham Risk Score | No Intervention | Patients in this arm will receive their Framingham Risk Score of having a heart attack. | |
| Framingham and Genetic Risk Score | Active Comparator | Patients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic Risk Score | Other | Patients in this arm will receive their genetic-informed risk for having a heart attack. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum LDL-cholesterol level | at 6 months post disclosure of CAD risk |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HDL-cholesterol | at 6 months post disclosure of CAD risk | |
| Change in systolic blood pressure measurements | at 6 months post disclosure of CAD risk | |
| Change in fasting blood glucose measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iftikhar Kullo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22151179 | Background | 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. | |
| 25708169 | Result | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| at 6 months post disclosure of CAD risk |
| Number of Subjects Who Initiated Treatment with Statin Medications | at 6 months post disclosure of CAD risk |
| Number of Subjects Who Used the Patient Portal at One Year | at 6 months post disclosure of CAD risk |
| Shared decision making (as assessed by survey) | Immediately after risk disclosure |
| Physician visit satisfaction (as assessed by survey) | Immediately after risk disclosure |
| Genetic counseling satisfaction and perceived personal control (as assessed by survey) | Immediately after risk disclosure |
| Body mass index measurements | at 6 months post disclosure of CAD risk |
| Waist circumference | at 6 months post disclosure of CAD risk |
| Blood pressure | at 6 months post disclosure of CAD risk |
| Dietary fat intake (assessed by survey) | at 6 months post disclosure of CAD risk |
| Physical activity (assessed by survey) | at 6 months post disclosure of CAD risk |
| Smoking cessation | at 6 months post disclosure of CAD risk |
| Anxiety (assessed by survey) | at 6 months post disclosure of CAD risk |
| Rating of test results information (assessed by survey) | Immediately after risk disclosure and 6 months afterwards |
| Understanding of genetic risk or family history risk (assessed by survey) | Immediately after risk disclosure and 6 months afterwards |
| Reaction to test results information (assessed by survey) | Immediately after risk disclosure |
| Perceived risk (assessed by survey) | Immediately after risk disclosure and 6 months afterwards |
| Intention to change (assessed by survey) | 3 months after risk disclosure |
| Recall and measure of locus control (assessed by survey) | 3 months after risk disclosure |
| Motivation and perceptions (assessed by survey) | 3 months after risk disclosure |
| Attitudes towards genome sequencing (assessed by survey) | 3 and 6 months after risk disclosure |
| Impact of events scale (assessed by survey) | 3 and 6 months after risk disclosure |
| Genetic knowledge (assessed by survey) | at enrollment and 6 months after risk disclosure |
| Attitude toward genetic testing (assessed by survey) | 6 months after risk disclosure |
| Decisional regret and treatment beliefs (assessed by survey) | 6 months after risk disclosure |
| Use of internet, electronic health record, social networks, and information sharing (assessed by survey) | 3 and 6 months after risk disclosure |
| 26271327 | Result | 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. |
| 26915630 | Result | 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. |
| 40151934 | Derived | Naderian M, Hamed ME, Vaseem AA, Norland K, Dikilitas O, Teymourzadeh A, Bailey KR, Kullo IJ. Effect of Disclosing a Polygenic Risk Score for Coronary Heart Disease on Adverse Cardiovascular Events. Circ Genom Precis Med. 2025 Apr;18(2):e004968. doi: 10.1161/CIRCGEN.124.004968. Epub 2025 Mar 28. |
| 30792945 | Derived | 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. |
| 28779015 | Derived | 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. |
| 27993947 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |