Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)

Официальное название

A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)

Обзор

The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.

Подробное описание

This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.

Вмешательства

• Генная терапия Disclosure of integrate risk score for coronary artery disease
  Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.

Первичные конечные точки

• Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing? [Срок оценки: 5 years]
• Does receiving an IRS report affect patient clinical measurements, including LDL-C levels? [Срок оценки: 5 years]

Вторичные конечные точки (3)

• Does the IRS identify those at elevated risk for CAD and future ASCVD events? [Срок оценки: 5 years]
• Does receiving an IRS report affect the incidence of CAD events? [Срок оценки: 5 years]
• Does receiving an IRS report affect participant understanding of their individual CAD risk? [Срок оценки: 5 years]

Критерии участия

Критерии включения

• ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
• No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
• Previously genotyped as part of a research study that enables recontact of participants
• Receiving primary care at a participating institution.

Критерии исключения

• Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
• Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
• Future use of statins contraindicated
• Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
• Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
• Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Mayo Clinic — Rochester
• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06542432 · 004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗