Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01936675
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : May 3, 2016
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Iftikhar J. Kullo, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE September 6, 2013
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
Change in serum LDL-cholesterol level [ Time Frame: at 6 months post disclosure of CAD risk ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Change in LDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Change in HDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ]
  • Change in blood pressure [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ]
  • Change in fasting blood sugar [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myocardial Infarction Genes (MI-GENES) Study
Official Title  ICMJE Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Infarction
  • Genomic Risk Communication
Intervention  ICMJE Other: Genetic Risk Score
Patients in this arm will receive their genetic-informed risk for having a heart attack.
Study Arms  ICMJE
  • No Intervention: Framingham Risk Score
    Patients in this arm will receive their Framingham Risk Score of having a heart attack.
  • Active Comparator: Framingham and Genetic Risk Score
    Patients in this arm will receive their Framingham Risk Score as well as their Genetic Risk Score of having a heart attack.
    Intervention: Other: Genetic Risk Score
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
216
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
200
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01936675
Other Study ID Numbers  ICMJE 12-001727
U01HG006379 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Iftikhar J. Kullo, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Human Genome Research Institute (NHGRI)
Investigators  ICMJE
Principal Investigator: Iftikhar Kullo, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP