Evidence map›Paper›PMID 26915630›Full record

Trial reportCirculation2016

Incorporating a Genetic Risk Score Into Coronary Heart Disease Risk Estimates: Effect on Low-Density Lipoprotein Cholesterol Levels (the MI-GENES Clinical Trial).

Iftikhar J Kullo, Hayan Jouni, Erin E Austin, Sherry-Ann Brown, Teresa M Kruisselbrink, Iyad N Isseh, Raad A Haddad, Tariq S Marroush, Khader Shameer, Janet E Olson and 5 more

4 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 165 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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)
NCT07039123 naactive not recruitingnot on this mapstarted 2025, after this paper: background citation

Polygenic Risk Score to Optimize Primary Prevention in Intermediate Risk Population (PERSONAL)

TypeinterventionalSponsorUniversity of BernRan2025 to 2027Enrolled205ConditionsPrimary Prevention of Cardiovascular DiseaseArmsPolygenic Risk Score for Coronary Artery Disease (PRS-CAD), Standardized Risk Communication Tool (SCORE2)
NCT07260552 not yet recruitingnot on this mapstarted 2027, after this paper: background citation

Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue (RESPOND) to Coronary Heart Disease

TypeobservationalSponsorMedical College of WisconsinRan2027 to 2031Enrolled200ConditionsCoronary Heart DiseaseArmsPolygenic risk score
3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Are There Any Effective Behavior Change Strategies for Communicating Genetic Risk in Obesity Prevention and Body Weight Reduction Interventions?Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
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  7. Behavioral impact of return of genetic test results for complex disease: Systematic review and meta-analysis.Health psychology : official journal of the Division of Health Psychology, American Psychological Association · 2018
    Pooled it
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  10. Risk scoring for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2017
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  17. 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
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105 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Iftikhar J KulloFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.). Kullo.Iftikhar@mayo.edu.
Hayan JouniFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Erin E AustinFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Sherry-Ann BrownFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Teresa M KruisselbrinkFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Iyad N IssehFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Raad A HaddadFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Tariq S MarroushFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Khader ShameerFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Janet E OlsonFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Ulrich BroeckelFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Robert C GreenFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Daniel J SchaidFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Victor M MontoriFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).
Kent R BaileyFrom the Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, MN (I.J.K., H.J., E.E.A., S.-A.B., T.M.K., I.N.I., R.A.H., T.S.M., K.S.); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (J.E.O., D.J.S., K.R.B.); Department of Pediatrics, Medicine and Physiology, Medical College of Wisconsin, Milwaukee (U.B.); Division of Genetics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.C.G.); and Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN (V.M.M.).

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
Integration of Whole Genome Sequencing into Clinical MedicineU01HG006500 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 2012 to 2016
$11.5M
EMR Phenotypes and Community Engaged Genomic AssociationsU01HG004599 · NHGRI · MAYO CLINIC ROCHESTER · PI CHUTE, CHRISTOPHER G · 2007 to 2010
$3.7M
NCATS NIH HHS UL1 TR000135NCATS NIH HHS UL1TR000135NHGRI NIH HHS HG006379NHGRI NIH HHS HG006500NHGRI NIH HHS HG04599NHGRI NIH HHS U01 HG004599NHGRI NIH HHS U01 HG006379NHGRI NIH HHS U01 HG006500
6 · The paper itself

Abstract

backgroundWhether knowledge of genetic risk for coronary heart disease (CHD) affects health-related outcomes is unknown. We investigated whether incorporating a genetic risk score (GRS) in CHD risk estimates lowers low-density lipoprotein cholesterol (LDL-C) levels. METHODS AND

resultsParticipants (n=203, 45-65 years of age, at intermediate risk for CHD, and not on statins) were randomly assigned to receive their 10-year probability of CHD based either on a conventional risk score (CRS) or CRS + GRS ((+)GRS). Participants in the (+)GRS group were stratified as having high or average/low GRS. Risk was disclosed by a genetic counselor followed by shared decision making regarding statin therapy with a physician. We compared the primary end point of LDL-C levels at 6 months and assessed whether any differences were attributable to changes in dietary fat intake, physical activity levels, or statin use. Participants (mean age, 59.4±5 years; 48% men; mean 10-year CHD risk, 8.5±4.1%) were allocated to receive either CRS (n=100) or (+)GRS (n=103). At the end of the study period, the (+)GRS group had a lower LDL-C than the CRS group (96.5±32.7 versus 105.9±33.3 mg/dL; P=0.04). Participants with high GRS had lower LDL-C levels (92.3±32.9 mg/dL) than CRS participants (P=0.02) but not participants with low GRS (100.9±32.2 mg/dL; P=0.18). Statins were initiated more often in the (+)GRS group than in the CRS group (39% versus 22%, P<0.01). No significant differences in dietary fat intake and physical activity levels were noted.

conclusionsDisclosure of CHD risk estimates that incorporated genetic risk information led to lower LDL-C levels than disclosure of CHD risk based on conventional risk factors alone. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01936675.

Indexed as

AgedAnxietyCholesterol, LDLComorbidityCoronary DiseaseDecision MakingDietary FatsFemaleFollow-Up StudiesGenetic CounselingGenetic Predisposition to DiseaseGenotypeHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedCholesterol, LDLDietary FatsHydroxymethylglutaryl-CoA Reductase Inhibitorscoronary diseasegenetic risk disclosuregenetic risk scoregenomicshydroxymethylglutaryl-CoA reductase inhibitorspolymorphism, single-nucleotideprevention & controlrandomized clinical trials

Identifiers

PMID26915630
PMCPMC4803581

What OpenQuestion holds

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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.