↓ Skip to main content

Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study

Overview of attention for article published in BMC Medical Genomics, August 2015
Altmetric Badge

Citations

dimensions_citation
16 Dimensions

Readers on

mendeley
99 Mendeley
You are seeing a free-to-access but limited selection of the activity Altmetric has collected about this research output. Click here to find out more.
Title
Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study
Published in
BMC Medical Genomics, August 2015
DOI 10.1186/s12920-015-0122-0
Pubmed ID
Authors

Iftikhar J. Kullo, Hayan Jouni, Janet E. Olson, Victor M. Montori, Kent R. Bailey

Abstract

Whether disclosure of a genetic risk score (GRS) for a common disease influences relevant clinical outcomes is unknown. We describe design of the Myocardial Infarction Genes (MI-GENES) Study, a randomized clinical trial to assess whether disclosing a GRS for coronary heart disease (CHD) leads to lowering of low-density lipoprotein cholesterol (LDL-C) levels. We performed an initial screening genotyping of 28 CHD susceptibility single-nucleotide polymorphisms (SNPs) that are not associated with blood pressure or lipid levels, in 1000 individuals from Olmsted County, Minnesota who were participants in the Mayo Clinic BioBank and met eligibility criteria. We calculated GRS based on 28 SNPs and will enroll 110 patients each in two CHD genomic risk categories: high (GRS ≥1.1), and average/low (GRS <1.1). The study coordinator will obtain informed consent for the study that includes placing genetic testing results in the electronic health record. Participants will undergo a blood draw and return 6-10 weeks later (Visit 2) once genotyping is completed and a GRS calculated. At this visit, patients will be randomized (1:1) to receive CHD risk estimates from a genetic counselor based on a conventional risk score (CRS) vs. GRS, followed by shared decision making with a physician regarding statin use. Three and six months following the disclosure of CHD risk, participants will return for measurement of fasting lipid levels and assessment of changes in dietary fat intake and physical activity levels. Psychosocial measures will be assessed at baseline and after disclosure of CHD risk. The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment. ClinicalTrials.gov registration number: NCT01936675 .

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 99 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Netherlands 1 1%
Unknown 98 99%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 15 15%
Researcher 12 12%
Student > Master 12 12%
Student > Bachelor 9 9%
Student > Postgraduate 8 8%
Other 16 16%
Unknown 27 27%
Readers by discipline Count As %
Medicine and Dentistry 23 23%
Nursing and Health Professions 9 9%
Agricultural and Biological Sciences 5 5%
Biochemistry, Genetics and Molecular Biology 5 5%
Psychology 5 5%
Other 19 19%
Unknown 33 33%