Evidence map›Paper›PMID 26271327›Full record

Trial reportBMC medical genomics2015

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

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

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medical genomics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01936675 nacompletednot on this map

Myocardial Infarction Genes (MI-GENES) Study - Using Genomic Data to Refine Risk Assessment for Heart Attack

TypeinterventionalSponsorMayo ClinicRan2013 to 2014Enrolled216ConditionsCoronary Artery Disease, Myocardial Infarction, Genomic Risk CommunicationArmsGenetic Risk Score
NCT04331535 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Pragmatic Randomized Trial of Polygenic Risk Scoring for Common Diseases in Primary Care

TypeinterventionalSponsorBoston VA Research Institute, Inc.Ran2020 to 2025Enrolled1,076ConditionsCoronary Artery Disease, Atrial Fibrillation, Type 2 Diabetes, Colorectal CancerArmsPolygenic risk score (PRS)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Risk scoring for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Trial
  3. Shared decision-making following disclosure of coronary heart disease genetic risk: results from a randomized clinical trial.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2017
    Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Returning Results: Let's Be Honest!Genetic testing and molecular biomarkers · 2017
    Article
  12. Review
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Iftikhar J KulloFrom the Division of Cardiovascular Diseases, Department of Medicine (IJK, HJ), Department of Health Sciences Research (JEO, KRB), Knowledge and Evaluation Research Unit (VMM), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Kullo.Iftikhar@mayo.edu.
Hayan JouniFrom the Division of Cardiovascular Diseases, Department of Medicine (IJK, HJ), Department of Health Sciences Research (JEO, KRB), Knowledge and Evaluation Research Unit (VMM), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Janet E OlsonFrom the Division of Cardiovascular Diseases, Department of Medicine (IJK, HJ), Department of Health Sciences Research (JEO, KRB), Knowledge and Evaluation Research Unit (VMM), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Victor M MontoriFrom the Division of Cardiovascular Diseases, Department of Medicine (IJK, HJ), Department of Health Sciences Research (JEO, KRB), Knowledge and Evaluation Research Unit (VMM), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Kent R BaileyFrom the Division of Cardiovascular Diseases, Department of Medicine (IJK, HJ), Department of Health Sciences Research (JEO, KRB), Knowledge and Evaluation Research Unit (VMM), Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.
Mayo Clinic · USMayo Clinic in Florida · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
Genomic Basis of Susceptibility to COVID-19 Infection and its ComplicationsU01HG006379 · NHGRI · MAYO CLINIC ROCHESTER · PI Richard R. Sharp · 2011 to 2026
$16.5M
EMR Phenotypes and Community Engaged Genomic AssociationsU01HG004599 · NHGRI · MAYO CLINIC ROCHESTER · PI CHUTE, CHRISTOPHER G · 2007 to 2010
$3.7M
NCATS NIH HHS UL1 TR000135NHGRI NIH HHS U01 HG004599NHGRI NIH HHS U01 HG006379NHGRI NIH HHS U01HG006379NHGRI NIH HHS U01HG04599
6 · The paper itself

Abstract

backgroundWhether 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

designWe 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 registrationClinicalTrials.gov registration number: NCT01936675 .

Indexed as

DisclosureGenetic Predisposition to DiseasePolymorphism, Single NucleotideCholesterol, LDLCoronary DiseaseDietary FatsFemaleFollow-Up StudiesHumansMaleMyocardial InfarctionRisk AssessmentRisk FactorsCholesterol, LDLDietary Fats

Identifiers

PMID26271327
PMCPMC4536729
OpenAlexW1924884835

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.