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.
Conditions:
🦠 Cardiovascular Risk Factor
🗓️ Study Start (Actual) January 2014
🗓️ Primary Completion (Estimated) December 2030
✅ Study Completion (Estimated) December 2032
👥 Enrollment (Estimated) 77000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • -
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 August 2019
  • First Submitted that Met QC Criteria 29 August 2019
  • First Posted 30 August 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024