University Hospitals
Cleveland, Ohio, 44106, United States
Location status: Recruiting
NCT Number: NCT04075162
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Cleveland, Ohio, 44106, United States
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Time frame: 1 year
Time frame: 1 year
Stress echocardiograms, myocardial perfusion imaging
Time frame: 1 year
Invasive coronary angiography
Time frame: 1 year
Percutaneous coronary interventions, coronary artery bypass grafting
Time frame: 1 year
Change in LDL cholesterol levels from baseline to 1 year
Time frame: 1 year
Change in LDL cholesterol levels from baseline to 1 year
Time frame: 1 year
Change in blood pressure from baseline to 1 year
Time frame: 1 year
Change in BMI from baseline to 1 year
Time frame: 1 year
Change in BMI from baseline to 1 year
Time frame: 1 year
Incidence of myocardial infarction
Time frame: 1 year
Incidence of myocardial infarction
Time frame: 1 year
Incidence of death
Time frame: 1 year
Incidence of lung cancer
Contact information is provided by the study sponsor or research team.
University Hospitals Cleveland Medical Center
Other
Acronym: CLARIFY
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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