Clinical trial NCT04075162: Community Benefit of No-charge Calcium Score Screening Program
Official title: Community Benefit of No-charge Calcium Score Screening Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Risk Factor
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 77000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Statin Prescription
timeFrame: 1 year
Secondary outcomes:
measure: Non-invasive coronary ischemia testing
timeFrame: 1 year
measure: Invasive coronary ischemia testing
timeFrame: 1 year
measure: Coronary revascularization procedures
timeFrame: 1 year
Other outcomes:
measure: LDL cholesterol
timeFrame: 1 year
measure: Total cholesterol
timeFrame: 1 year
measure: Blood pressure
timeFrame: 1 year
measure: Body mass index
timeFrame: 1 year
measure: Serum Triglycerides
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Death
timeFrame: 1 year
measure: Lung cancer
timeFrame: 1 year
Locations:
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.