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Myocardial Infarction Genes (MI-GENES) Study (MI-GENES)

Primary Purpose

Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic Risk Score
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Framingham Risk Score

Framingham and Genetic Risk Score

Arm Description

Patients in this arm will receive their Framingham Risk Score of having a heart attack.

Patients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack.

Outcomes

Primary Outcome Measures

Change in serum LDL-cholesterol level

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2013
Last Updated
May 2, 2016
Sponsor
Mayo Clinic
Collaborators
National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT01936675
Brief Title
Myocardial Infarction Genes (MI-GENES) Study
Acronym
MI-GENES
Official Title
Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Human Genome Research Institute (NHGRI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication
Keywords
Coronary Artery Disease, Myocardial Infarction, Genomic Risk Communication, Risk Stratification

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Framingham Risk Score
Arm Type
No Intervention
Arm Description
Patients in this arm will receive their Framingham Risk Score of having a heart attack.
Arm Title
Framingham and Genetic Risk Score
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack.
Intervention Type
Other
Intervention Name(s)
Genetic Risk Score
Intervention Description
Patients in this arm will receive their genetic-informed risk for having a heart attack.
Primary Outcome Measure Information:
Title
Change in serum LDL-cholesterol level
Time Frame
at 6 months post disclosure of CAD risk
Secondary Outcome Measure Information:
Title
Change in HDL-cholesterol
Time Frame
at 6 months post disclosure of CAD risk
Title
Change in systolic blood pressure measurements
Time Frame
at 6 months post disclosure of CAD risk
Title
Change in fasting blood glucose measurements
Time Frame
at 6 months post disclosure of CAD risk
Title
Number of Subjects Who Initiated Treatment with Statin Medications
Time Frame
at 6 months post disclosure of CAD risk
Title
Number of Subjects Who Used the Patient Portal at One Year
Time Frame
at 6 months post disclosure of CAD risk
Title
Shared decision making (as assessed by survey)
Time Frame
Immediately after risk disclosure
Title
Physician visit satisfaction (as assessed by survey)
Time Frame
Immediately after risk disclosure
Title
Genetic counseling satisfaction and perceived personal control (as assessed by survey)
Time Frame
Immediately after risk disclosure
Title
Body mass index measurements
Time Frame
at 6 months post disclosure of CAD risk
Title
Waist circumference
Time Frame
at 6 months post disclosure of CAD risk
Title
Blood pressure
Time Frame
at 6 months post disclosure of CAD risk
Title
Dietary fat intake (assessed by survey)
Time Frame
at 6 months post disclosure of CAD risk
Title
Physical activity (assessed by survey)
Time Frame
at 6 months post disclosure of CAD risk
Title
Smoking cessation
Time Frame
at 6 months post disclosure of CAD risk
Title
Anxiety (assessed by survey)
Time Frame
at 6 months post disclosure of CAD risk
Title
Rating of test results information (assessed by survey)
Time Frame
Immediately after risk disclosure and 6 months afterwards
Title
Understanding of genetic risk or family history risk (assessed by survey)
Time Frame
Immediately after risk disclosure and 6 months afterwards
Title
Reaction to test results information (assessed by survey)
Time Frame
Immediately after risk disclosure
Title
Perceived risk (assessed by survey)
Time Frame
Immediately after risk disclosure and 6 months afterwards
Title
Intention to change (assessed by survey)
Time Frame
3 months after risk disclosure
Title
Recall and measure of locus control (assessed by survey)
Time Frame
3 months after risk disclosure
Title
Motivation and perceptions (assessed by survey)
Time Frame
3 months after risk disclosure
Title
Attitudes towards genome sequencing (assessed by survey)
Time Frame
3 and 6 months after risk disclosure
Title
Impact of events scale (assessed by survey)
Time Frame
3 and 6 months after risk disclosure
Title
Genetic knowledge (assessed by survey)
Time Frame
at enrollment and 6 months after risk disclosure
Title
Attitude toward genetic testing (assessed by survey)
Time Frame
6 months after risk disclosure
Title
Decisional regret and treatment beliefs (assessed by survey)
Time Frame
6 months after risk disclosure
Title
Use of internet, electronic health record, social networks, and information sharing (assessed by survey)
Time Frame
3 and 6 months after risk disclosure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iftikhar Kullo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22151179
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.
Results Reference
background
PubMed Identifier
25708169
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.
Results Reference
result
PubMed Identifier
26271327
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.
Results Reference
result
PubMed Identifier
26915630
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.
Results Reference
result
PubMed Identifier
30792945
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.
Results Reference
derived
PubMed Identifier
28779015
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.
Results Reference
derived
PubMed Identifier
27993947
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.
Results Reference
derived

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Myocardial Infarction Genes (MI-GENES) Study

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