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Community Benefit of No-charge Calcium Score Screening Program

Community Benefit of No-charge Calcium Score Screening Program

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04075162
Acronym
CLARIFY
Enrollment
77000
Registered
2019-08-30
Start date
2014-01-01
Completion date
2030-12-01
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

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.

Interventions

None listed

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Statin Prescription1 year

Secondary

MeasureTime frameDescription
Non-invasive coronary ischemia testing1 yearStress echocardiograms, myocardial perfusion imaging
Invasive coronary ischemia testing1 yearInvasive coronary angiography
Coronary revascularization procedures1 yearPercutaneous coronary interventions, coronary artery bypass grafting

Countries

United States

Contacts

CONTACTSadeer Al-Kindi, M.D.
sadeer.alkindi@uhhospitals.org2168441000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026