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NCT04075162 · ClinicalTrials.gov registry record
Community Benefit of No-charge Calcium Score Screening Program
A clinical trial of Cardiovascular Risk Factor, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- 77,000
- Enrollment target
- 1
- Study location
NCT04075162 is a study of Cardiovascular Risk Factor that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 77,000 participants, above the 584-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (13085% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04075162, a study of Cardiovascular Risk Factor, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- 77,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Study Locations (1)
Ohio
- University Hospitals - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77,000 participants |
| Start Date | 2014-01 |
| Est. Completion | 2032-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04075162
The ClinicalTrials.gov registry entry for NCT04075162 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 77,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 584-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (13085% higher). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cardiovascular Risk Factor appearing as the primary indexed condition, and to 0 interventions.
NCT04075162 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04075162 about?
NCT04075162 is a clinical study titled "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 ...
What is the current status of trial NCT04075162?
This trial is currently recruiting. The enrollment target is 77,000 participants. The study started on 2014-01. Estimated completion is 2032-12.
What conditions does trial NCT04075162 study?
This clinical trial studies the following conditions: Cardiovascular Risk Factor.
Who is sponsoring clinical trial NCT04075162?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04075162 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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