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Recruiting

NCT Number: NCT04075162

Community Benefit of No-charge Calcium Score Screening Program

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Clinical Research Specialist

CONTACT

2168445125

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Statin Prescription

    Time frame: 1 year

Secondary outcomes

  1. Non-invasive coronary ischemia testing

    Time frame: 1 year

    Stress echocardiograms, myocardial perfusion imaging

  2. Invasive coronary ischemia testing

    Time frame: 1 year

    Invasive coronary angiography

  3. Coronary revascularization procedures

    Time frame: 1 year

    Percutaneous coronary interventions, coronary artery bypass grafting

Other outcomes

  1. LDL cholesterol

    Time frame: 1 year

    Change in LDL cholesterol levels from baseline to 1 year

  2. Total cholesterol

    Time frame: 1 year

    Change in LDL cholesterol levels from baseline to 1 year

  3. Blood pressure

    Time frame: 1 year

    Change in blood pressure from baseline to 1 year

  4. Body mass index

    Time frame: 1 year

    Change in BMI from baseline to 1 year

  5. Serum Triglycerides

    Time frame: 1 year

    Change in BMI from baseline to 1 year

  6. Myocardial infarction

    Time frame: 1 year

    Incidence of myocardial infarction

  7. Stroke

    Time frame: 1 year

    Incidence of myocardial infarction

  8. Death

    Time frame: 1 year

    Incidence of death

  9. Lung cancer

    Time frame: 1 year

    Incidence of lung cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Sadeer Al-Kindi, M.D.

CONTACT

[email protected]

2168441000

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Acronym: CLARIFY

Important dates

Study start
2014
Primary completion
2030
Study completion
2032
First posted
Aug 30, 2019
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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