Myocardial Infarction Genes (MI-GENES) Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Iftikhar J. Kullo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01936675
First received: September 3, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Other: Genetic Risk Score

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in LDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HDL-cholesterol [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]
  • Change in fasting blood sugar [ Time Frame: Throughout the duration of the study (up to 12 months following enrollment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Genetic Risk Score
Patients in this arm will receive their genetic-informed risk for having a heart attack.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936675

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Iftikhar Kullo, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Iftikhar J. Kullo, Professor of Medicine, Division of Cardiovascular Diseases, Department of Internal Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01936675     History of Changes
Other Study ID Numbers: 12-001727, U01HG006379
Study First Received: September 3, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Coronary Artery Disease
Myocardial Infarction
Genomic Risk Communication
Risk Stratification

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014