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Not yet recruiting NCT05175651

Prospective Electronic Polygenic Risk Study - Second Phase

No phase Interventional Coronary Artery Disease Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genetic risk assessment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Glaucoma. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study will investigate the role of polygenic risk scores (PRS) in preventive health.

Detailed description

This study will investigate the role of polygenic risk scores (PRS) in preventive health. Specifically, the purpose of this study is to determine whether knowledge of the degree of coronary artery disease (CAD) genetic risk or glaucoma genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making as well as clinical outcomes during short-term (6-month / 2-year) and long-term (3-year / 5-year) follow-up. A CAD and glaucoma PRS will be calculated for all study participants, with participants randomized to receiving either their CAD or glaucoma PRS. This study design allows for causal attribution of preventive actions and clinical outcomes to the receipt and degree of genetic risk. The design is informed by a pilot (MyGeneRank) and phase 1 (PEPRS first phase) study, with the key extensions being the addition of randomization and increasing the study population size to power causal association with long-term, hard clinical outcomes.

Interventions

  • Behavioral Genetic risk assessment
    A coronary artery disease (CAD) and glaucoma polygenic risk scores (PRS) will be calculated for all study participants, with participants randomized to receiving either their CAD or glaucoma PRS.

Primary outcome measures

  • Composite MACE in intermediate to high clinical risk population [Time frame: 5 years post enrollment]
Secondary outcome measures (9)
  • Composite MACE in high PRS [Time frame: 5 years post enrollment]
  • MACE Components [Time frame: 5 years post enrollment]
  • Treated Glaucoma [Time frame: 5 years post enrollment]
  • LDL-C lowering [Time frame: 5 years post enrollment]
  • Statin or other lipid lowering therapy initiation or intensification [Time frame: 1 year post enrollment]
  • Statin or other lipid lowering therapy persistence [Time frame: 2 years post enrollment]
  • Statin or other lipid lowering therapy adherence [Time frame: 2 years post enrollment]
  • Glaucoma screening [Time frame: 2 years post enrollment]
  • Physician Utility [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 45 ≥ Age < 65
  • ASCVD Risk Score > 7.5% as defined by the standard pooled cohort equation
  • Access to and ability to use a smartphone

Exclusion criteria

  • Prior diagnosis of coronary disease as defined by prior myocardial infarction (STEMI or NSTEMI), or revascularization (stent or coronary artery bypass grafting)
  • Prior diagnosis or treatment of glaucoma
  • Cerebrovascular disease with history of ischemic stroke, TIA, carotid endarterectomy, carotid artery stenting
  • Peripheral arterial disease with history of claudication, revascularization (stents or bypass)
  • Current and active high-intensity statin prescription (rosuvastatin 20 mg, rosuvastatin 40 mg, atorvastatin 40 mg and atorvastatin 80 mg)
  • Anti-PCSK9 therapy
  • Lipid apheresis therapy
  • Currently enrolled in a clinical trial for lipid lowering therapy
  • Known statin intolerance to 2 or more statins in the past

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on C PMID 30894319
  • Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of inc PMID 20167359
  • Macedo AF, Taylor FC, Casas JP, Adler A, Prieto-Merino D, Ebrahim S. Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis. BMC Med. 2014 Mar 22;12:51. doi: 10.1186/1741-7015-12-51. PMID 24655568
  • Mega JL, Stitziel NO, Smith JG, Chasman DI, Caulfield M, Devlin JJ, Nordio F, Hyde C, Cannon CP, Sacks F, Poulter N, Sever P, Ridker PM, Braunwald E, Melander O, Kathiresan S, Sabatine MS. Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials. Lancet. 2015 Jun 6;385(9984):2264-2271. doi: 10.1016/S0140-6736(14 PMID 25748612
  • Khera AV, Emdin CA, Drake I, Natarajan P, Bick AG, Cook NR, Chasman DI, Baber U, Mehran R, Rader DJ, Fuster V, Boerwinkle E, Melander O, Orho-Melander M, Ridker PM, Kathiresan S. Genetic Risk, Adherence to a Healthy Lifestyle, and Coronary Disease. N Engl J Med. 2016 Dec 15;375(24):2349-2358. doi: 10.1056/NEJMoa1605086. Epub 2016 Nov 13. PMID 27959714
  • Scott AW, Bressler NM, Ffolkes S, Wittenborn JS, Jorkasky J. Public Attitudes About Eye and Vision Health. JAMA Ophthalmol. 2016 Oct 1;134(10):1111-1118. doi: 10.1001/jamaophthalmol.2016.2627. PMID 27490785
  • Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PMID 24974815
  • Moyer VA; U.S. Preventive Services Task Force. Screening for glaucoma: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013 Oct 1;159(7):484-9. doi: 10.7326/0003-4819-159-6-201309170-00686. PMID 24325017

Identifiers

NCT: NCT05175651 · IRB-21-7860

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗