Coronary Artery DiseaseMI-GENESNCT01936675

Myocardial Infarction Genes (MI-GENES) Study

A study testing Genetic Risk Score in people with Coronary Artery Disease and Myocardial Infarction, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 45 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication
What is being tested?: Genetic Risk Score
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Nov 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Taking statin or other lipid lowering medications
Patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication
Being tested: Genetic Risk Score
Keywords: Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification
Medical subject headings: Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Genetic Risk ScoreOther
Patients in this arm will receive their genetic-informed risk for having a heart attack.

Study groups in NCT01936675
Study group	Role	What they receive
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. Receives: Other: Genetic Risk Score

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in serum LDL-cholesterol level
Measured: at 6 months post disclosure of CAD risk

Secondary outcomes (28)

Change in HDL-cholesterol
Measured: at 6 months post disclosure of CAD risk
Change in systolic blood pressure measurements
Measured: at 6 months post disclosure of CAD risk
Change in fasting blood glucose measurements
Measured: at 6 months post disclosure of CAD risk
Number of Subjects Who Initiated Treatment with Statin Medications
Measured: at 6 months post disclosure of CAD risk
Number of Subjects Who Used the Patient Portal at One Year
Measured: at 6 months post disclosure of CAD risk
Shared decision making (as assessed by survey)
Measured: Immediately after risk disclosure
Physician visit satisfaction (as assessed by survey)
Measured: Immediately after risk disclosure
Genetic counseling satisfaction and perceived personal control (as assessed by survey)
Measured: Immediately after risk disclosure
Body mass index measurements
Measured: at 6 months post disclosure of CAD risk
Waist circumference
Measured: at 6 months post disclosure of CAD risk
Blood pressure
Measured: at 6 months post disclosure of CAD risk
Dietary fat intake (assessed by survey)
Measured: at 6 months post disclosure of CAD risk
Physical activity (assessed by survey)
Measured: at 6 months post disclosure of CAD risk
Smoking cessation
Measured: at 6 months post disclosure of CAD risk
Anxiety (assessed by survey)
Measured: at 6 months post disclosure of CAD risk
Rating of test results information (assessed by survey)
Measured: Immediately after risk disclosure and 6 months afterwards
Understanding of genetic risk or family history risk (assessed by survey)
Measured: Immediately after risk disclosure and 6 months afterwards
Reaction to test results information (assessed by survey)
Measured: Immediately after risk disclosure
Perceived risk (assessed by survey)
Measured: Immediately after risk disclosure and 6 months afterwards
Intention to change (assessed by survey)
Measured: 3 months after risk disclosure
Recall and measure of locus control (assessed by survey)
Measured: 3 months after risk disclosure
Motivation and perceptions (assessed by survey)
Measured: 3 months after risk disclosure
Attitudes towards genome sequencing (assessed by survey)
Measured: 3 and 6 months after risk disclosure
Impact of events scale (assessed by survey)
Measured: 3 and 6 months after risk disclosure
Genetic knowledge (assessed by survey)
Measured: at enrollment and 6 months after risk disclosure
Attitude toward genetic testing (assessed by survey)
Measured: 6 months after risk disclosure
Decisional regret and treatment beliefs (assessed by survey)
Measured: 6 months after risk disclosure
Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
Measured: 3 and 6 months after risk disclosure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Nov 2014

First posted6 Sep 2013 (estimated)
Study startJul 2013
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01936675
Sponsor's protocol ID: 12-001727
Other IDs: U01HG006379
Acronym: MI-GENES
Status last verified: May 2016
First submitted: 3 Sep 2013
Last updated: 3 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 22151179
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.
PubMed 25708169
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.
PubMed 26271327
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.
PubMed 26915630
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.
PubMed 40151934
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.
PubMed 30792945
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.
PubMed 28779015
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.
PubMed 27993947

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease

All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
ClinicalTrials.gov ID: NCT01936675
Acronym / sponsor ID: MI-GENES / 12-001727
Conditions: Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication
Keywords: Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Human Genome Research Institute (NHGRI)
Study start: Jul 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 6 Sep 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Other: Genetic Risk ScorePatients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack.

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Taking statin or other lipid lowering medications
Patients with a history of myocardial infarction, coronary artery disease, or other atherosclerotic medical conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Genetic Risk ScorePatients in this arm will receive their genetic-informed risk for having a heart attack.	Other	Framingham and Genetic Risk Score

Primary outcome

Change in serum LDL-cholesterol level
Time frame: at 6 months post disclosure of CAD risk

28 secondary outcomes

Change in HDL-cholesterol
Time frame: at 6 months post disclosure of CAD risk
Change in systolic blood pressure measurements
Time frame: at 6 months post disclosure of CAD risk
Change in fasting blood glucose measurements
Time frame: at 6 months post disclosure of CAD risk
Number of Subjects Who Initiated Treatment with Statin Medications
Time frame: at 6 months post disclosure of CAD risk
Number of Subjects Who Used the Patient Portal at One Year
Time frame: at 6 months post disclosure of CAD risk
Shared decision making (as assessed by survey)
Time frame: Immediately after risk disclosure
Physician visit satisfaction (as assessed by survey)
Time frame: Immediately after risk disclosure
Genetic counseling satisfaction and perceived personal control (as assessed by survey)
Time frame: Immediately after risk disclosure
Body mass index measurements
Time frame: at 6 months post disclosure of CAD risk
Waist circumference
Time frame: at 6 months post disclosure of CAD risk
Blood pressure
Time frame: at 6 months post disclosure of CAD risk
Dietary fat intake (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Physical activity (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Smoking cessation
Time frame: at 6 months post disclosure of CAD risk
Anxiety (assessed by survey)
Time frame: at 6 months post disclosure of CAD risk
Rating of test results information (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Understanding of genetic risk or family history risk (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Reaction to test results information (assessed by survey)
Time frame: Immediately after risk disclosure
Perceived risk (assessed by survey)
Time frame: Immediately after risk disclosure and 6 months afterwards
Intention to change (assessed by survey)
Time frame: 3 months after risk disclosure
Recall and measure of locus control (assessed by survey)
Time frame: 3 months after risk disclosure
Motivation and perceptions (assessed by survey)
Time frame: 3 months after risk disclosure
Attitudes towards genome sequencing (assessed by survey)
Time frame: 3 and 6 months after risk disclosure
Impact of events scale (assessed by survey)
Time frame: 3 and 6 months after risk disclosure
Genetic knowledge (assessed by survey)
Time frame: at enrollment and 6 months after risk disclosure
Attitude toward genetic testing (assessed by survey)
Time frame: 6 months after risk disclosure
Decisional regret and treatment beliefs (assessed by survey)
Time frame: 6 months after risk disclosure
Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
Time frame: 3 and 6 months after risk disclosure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
Background: PubMed 22151179Ding 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.
Results publication: PubMed 25708169Robinson 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.
Results publication: PubMed 26271327Kullo 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.
Results publication: PubMed 26915630Kullo 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.
Derived from this study: PubMed 40151934Naderian 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.
Derived from this study: PubMed 30792945Brown 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.
Derived from this study: PubMed 28779015Brown 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.
Derived from this study: PubMed 27993947Jouni 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.
Individual participant dataSharing planned: No

Related trials for Coronary Artery Disease

Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Iftikhar Kullo, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Genetic Risk Score in people with Coronary Artery Disease and Myocardial Infarction, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum LDL-cholesterol level (time frame: at 6 months post disclosure of CAD risk). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01936675, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.