Community Benefit of No-charge Calcium Score Screening Program

NCT04075162 | Recruiting

• 1 other identifier: 20190995
• Study Type: observational
• Target: 77,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Statin Prescription

  1 year

Secondary Outcomes (3)

• Non-invasive coronary ischemia testing

  1 year

• Invasive coronary ischemia testing

  1 year

• Coronary revascularization procedures

  1 year

Other Outcomes (9)

• LDL cholesterol

  1 year

• Total cholesterol

  1 year

• Blood pressure

  1 year

Study Arms (2)

Low charge CAC

Patients receiving CAC for Cardiovascular disease risk screening at low charge (99 USD)

No charge CAC

Patients receiving CAC for Cardiovascular disease risk screening at no charge

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who received a no-cost Coronary Artery Calcium (CAC) CT scan at University Hospitals (Cleveland, Oh) starting in January 1, 2014.

You may qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (6)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

Central Study Contacts

Sadeer Al-Kindi, M.D.

CONTACT

2168441000; sadeer.alkindi@uhhospitals.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Cardiovascular Medicine

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 30, 2019
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)