NCT01936675

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

September 3, 2013

Last Update Submit

May 2, 2016

Conditions

Coronary Artery DiseaseMyocardial InfarctionGenomic Risk Communication

Keywords

Coronary Artery DiseaseMyocardial InfarctionGenomic Risk CommunicationRisk Stratification

Outcome Measures

Primary Outcomes (1)

  • Change in serum LDL-cholesterol level

    at 6 months post disclosure of CAD risk

Secondary Outcomes (28)

  • 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

    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

  • +23 more secondary outcomes

Study Arms (2)

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.

Other: Genetic Risk Score

Interventions

Genetic Risk ScoreOTHER

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

Framingham and Genetic Risk Score

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (8)

  • 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.

    PMID: 22151179BACKGROUND

  • 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.

    PMID: 25708169RESULT

  • 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.

    PMID: 26271327RESULT

  • 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.

    PMID: 26915630RESULT

  • 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.

    PMID: 40151934DERIVED

  • 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.

    PMID: 30792945DERIVED

  • 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.

    PMID: 28779015DERIVED

  • 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.

    PMID: 27993947DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Iftikhar Kullo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Division of Cardiovascular Diseases, Department of Internal Medicine

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)