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Идёт набор NCT04075162

Community Benefit of No-charge Calcium Score Screening Program

— Наблюдательное Cardiovascular Risk Factor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cardiovascular Risk Factor. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Current approaches in primary prevention for cardiovascular disease are based on probabilistic approaches to estimate risk, using many of the widely available cardiovascular risks scores, with over 100 such scoring systems currently available throughout the world. The rationale for this practice is to select those individuals at greatest risk for more intense targets, reduce risk of treatment to those at minimal risk, and to maximize the cost-effectiveness of treatment. A recent Cochrane Systematic Review assessed the practice of using risk scores to select individuals for the primary prevention of cardiovascular disease. 3 The principal finding of the systematic review was that there was little or no effect of providing clinicians with cardiovascular risk scores when compared to standard of care (5.4% versus 5.3%; relative risk 1.01, 95% confidence intervals 0.95 to 1.08). The authors concluded that there is major uncertainty whether current strategies for providing risk scores and called for further research to address this concern. Extent of coronary artery calcium (CAC) is a strong risk marker for coronary events, with evidence mainly derived from observational studies and from prospective non-randomized studies. CAC, although endorsed for intermediate risk patients, is not widely adopted due to barriers in reimbursement. The cost of the test ranges between 100 and 300 USD in the United States, which may have limited the wide adoption of the test. Whether reducing the cost burden for CAC increases utilization for routine screening and its influence on physician practices and downstream testing is largely unknown. University Hospitals started offering low charge CAC (99$) since 2014. In 2017, University Hospitals started offering CAC for no charge for patients to improve access to this test, which has not traditionally been covered by insurance companies. The impact of no-charge CAC has never been studied.

Первичные конечные точки

  • Statin Prescription [Срок оценки: 1 year]
Вторичные конечные точки (3)
  • Non-invasive coronary ischemia testing [Срок оценки: 1 year]
  • Invasive coronary ischemia testing [Срок оценки: 1 year]
  • Coronary revascularization procedures [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Received Coronary Artery Calcium (CAC) CT scan at University Hospitals starting in January 1, 2014.

Критерии исключения

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University Hospitals — Cleveland

Публикации

  • Singh P, Hoori A, Freeze J, Hu T, Tashtish N, Gilkeson R, Li S, Rajagopalan S, Wilson DL, Al-Kindi S. Leveraging calcium score CT radiomics for heart failure risk prediction. Sci Rep. 2024 Nov 6;14(1):26898. doi: 10.1038/s41598-024-77269-x. PMID 39505933
  • Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Rajagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. Sci Rep. 2024 May 15;14(1):11134. doi: 10.1038/s41598-024-60584-8. PMID 38750142
  • Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Ra-Jagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. ArXiv [Preprint]. 2023 Aug 23:arXiv:2308.12224v1. PMID 37664409
  • Siva Kumar S, Al-Kindi S, Tashtish N, Rajagopalan V, Fu P, Rajagopalan S, Madabhushi A. Machine learning derived ECG risk score improves cardiovascular risk assessment in conjunction with coronary artery calcium scoring. Front Cardiovasc Med. 2022 Oct 5;9:976769. doi: 10.3389/fcvm.2022.976769. eCollection 2022. PMID 36277775
  • Al-Kindi S, Tashtish N, Rashid I, Sullivan C, Neeland IJ, Robinson M, Gross EM, Shaw L, Cainzos-Achirica M, Nasir K, Kreatsoulas C, Gilkeson R, Simon DI, Rajagopalan S. Impact of low/no-charge coronary artery calcium scoring on statin eligibility and outcomes in women: The CLARIFY study. Am J Prev Cardiol. 2022 Sep 11;12:100392. doi: 10.1016/j.ajpc.2022.100392. eCollection 2022 Dec. PMID 36157553
  • Khawaja T, Janus SE, Tashtish N, Janko M, Baeza C, Gilkeson R, Al-Kindi SG, Rajagopalan S. Prevalence of thoracic aortic aneurysm in patients referred for no/low-charge coronary artery calcium scoring: Insights from the CLARIFY registry. Am J Prev Cardiol. 2022 Aug 30;12:100378. doi: 10.1016/j.ajpc.2022.100378. eCollection 2022 Dec. PMID 36106308

Идентификаторы

NCT: NCT04075162 · 20190995

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗