Community Benefit of No-charge Calcium Score Screening Program

Cardiovascular Risk Factor Clinical Trial

— CLARIFY  

Official title:

Community Benefit of No-charge Calcium Score Screening Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075162
• Other study ID #: 20190995
• Status: Recruiting
• Start date: January 2014
• Est. completion date: December 2032

Study information

• Verified date: June 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: Sadeer Al-Kindi, M.D.
• Phone: 2168441000
• Email: sadeer.alkindi[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77000
• Est. completion date: December 2032
• Est. primary completion date: December 2030
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Locations

Country	Name	City	State
United States	University Hospitals	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL cholesterol	Change in LDL cholesterol levels from baseline to 1 year	1 year
Other	Total cholesterol	Change in LDL cholesterol levels from baseline to 1 year	1 year
Other	Blood pressure	Change in blood pressure from baseline to 1 year	1 year
Other	Body mass index	Change in BMI from baseline to 1 year	1 year
Other	Serum Triglycerides	Change in BMI from baseline to 1 year	1 year
Other	Myocardial infarction	Incidence of myocardial infarction	1 year
Other	Stroke	Incidence of myocardial infarction	1 year
Other	Death	Incidence of death	1 year
Other	Lung cancer	Incidence of lung cancer	1 year
Primary	Statin Prescription		1 year
Secondary	Non-invasive coronary ischemia testing	Stress echocardiograms, myocardial perfusion imaging	1 year
Secondary	Invasive coronary ischemia testing	Invasive coronary angiography	1 year
Secondary	Coronary revascularization procedures	Percutaneous coronary interventions, coronary artery bypass grafting	1 year