Community Benefit of No-charge Calcium Score Screening Program
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Risk Factor. Basic parameters: 18 years — 100 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
- United States
- 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
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.
Primary outcome measures
- Statin Prescription [Time frame: 1 year]
Secondary outcome measures (3)
- Non-invasive coronary ischemia testing [Time frame: 1 year]
- Invasive coronary ischemia testing [Time frame: 1 year]
- Coronary revascularization procedures [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Received Coronary Artery Calcium (CAC) CT scan at University Hospitals starting in January 1, 2014.
Exclusion criteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University Hospitals — Cleveland
Publications
- 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
Identifiers
NCT: NCT04075162 · 20190995