Community Benefit of No-charge Calcium Score Screening Program

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

77,000 Participants
are grouped into 2 trial groups
Group A: Low charge CAC
Group B: No charge CAC

Trial outcomes

Primary outcomes

1

Statin Prescription

Time frame
1 year

Secondary outcomes

1

Non-invasive coronary ischemia testing

Stress echocardiograms, myocardial perfusion imaging

Time frame
1 year
2

Invasive coronary ischemia testing

Invasive coronary angiography

Time frame
1 year
3

Coronary revascularization procedures

Percutaneous coronary interventions, coronary artery bypass grafting

Time frame
1 year

Other outcomes

1

LDL cholesterol

Change in LDL cholesterol levels from baseline to 1 year

Time frame
1 year
2

Total cholesterol

Change in LDL cholesterol levels from baseline to 1 year

Time frame
1 year
3

Blood pressure

Change in blood pressure from baseline to 1 year

Time frame
1 year
4

Body mass index

Change in BMI from baseline to 1 year

Time frame
1 year

Sponsors and contacts

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