Community Benefit of No-charge Calcium Score Screening Program (CLARIFY)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Risk Factor

• Study Type: Observational
• Enrollment (Estimated): 77000

Contacts and Locations

• Study Contact: Name: Sadeer Al-Kindi, M.D.; Phone Number: 2168441000; Email: sadeer.alkindi@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Clinical Research Specialist; Phone Number: 2168445125

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Statin Prescription	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive coronary ischemia testing	Stress echocardiograms, myocardial perfusion imaging	1 year
Invasive coronary ischemia testing	Invasive coronary angiography	1 year
Coronary revascularization procedures	Percutaneous coronary interventions, coronary artery bypass grafting	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL cholesterol	Change in LDL cholesterol levels from baseline to 1 year	1 year
Total cholesterol	Change in LDL cholesterol levels from baseline to 1 year	1 year
Blood pressure	Change in blood pressure from baseline to 1 year	1 year
Body mass index	Change in BMI from baseline to 1 year	1 year
Serum Triglycerides	Change in BMI from baseline to 1 year	1 year
Myocardial infarction	Incidence of myocardial infarction	1 year
Stroke	Incidence of myocardial infarction	1 year
Death	Incidence of death	1 year
Lung cancer	Incidence of lung cancer	1 year

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20190995

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No