Cargando…
Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study
BACKGROUND: 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)...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4536729/ https://www.ncbi.nlm.nih.gov/pubmed/26271327 http://dx.doi.org/10.1186/s12920-015-0122-0 |
_version_ | 1782385787873001472 |
---|---|
author | Kullo, Iftikhar J. Jouni, Hayan Olson, Janet E. Montori, Victor M. Bailey, Kent R. |
author_facet | Kullo, Iftikhar J. Jouni, Hayan Olson, Janet E. Montori, Victor M. Bailey, Kent R. |
author_sort | Kullo, Iftikhar J. |
collection | PubMed |
description | BACKGROUND: 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. METHODS AND DESIGN: 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. DISCUSSION: The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT01936675. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12920-015-0122-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4536729 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-45367292015-08-15 Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study Kullo, Iftikhar J. Jouni, Hayan Olson, Janet E. Montori, Victor M. Bailey, Kent R. BMC Med Genomics Study Protocol BACKGROUND: 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. METHODS AND DESIGN: 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. DISCUSSION: The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT01936675. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12920-015-0122-0) contains supplementary material, which is available to authorized users. BioMed Central 2015-08-15 /pmc/articles/PMC4536729/ /pubmed/26271327 http://dx.doi.org/10.1186/s12920-015-0122-0 Text en © Kullo et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Kullo, Iftikhar J. Jouni, Hayan Olson, Janet E. Montori, Victor M. Bailey, Kent R. Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title | Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title_full | Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title_fullStr | Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title_full_unstemmed | Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title_short | Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study |
title_sort | design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the myocardial infarction genes (mi-genes) study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4536729/ https://www.ncbi.nlm.nih.gov/pubmed/26271327 http://dx.doi.org/10.1186/s12920-015-0122-0 |
work_keys_str_mv | AT kulloiftikharj designofarandomizedcontrolledtrialofdisclosinggenomicriskofcoronaryheartdiseasethemyocardialinfarctiongenesmigenesstudy AT jounihayan designofarandomizedcontrolledtrialofdisclosinggenomicriskofcoronaryheartdiseasethemyocardialinfarctiongenesmigenesstudy AT olsonjanete designofarandomizedcontrolledtrialofdisclosinggenomicriskofcoronaryheartdiseasethemyocardialinfarctiongenesmigenesstudy AT montorivictorm designofarandomizedcontrolledtrialofdisclosinggenomicriskofcoronaryheartdiseasethemyocardialinfarctiongenesmigenesstudy AT baileykentr designofarandomizedcontrolledtrialofdisclosinggenomicriskofcoronaryheartdiseasethemyocardialinfarctiongenesmigenesstudy |