title: The Case For and Against a Coronary Artery Calcium Trial: Means, Motive, and Opportunity.
abstract: Numerous observational studies have shown that coronary artery calcium (CAC) imaging can improve cardiovascular risk assessment in asymptomatic adults. Whether CAC imaging can improve cardiovascular outcomes as part of an overall risk reduction strategy compared to alternative care approaches has not been demonstrated in clinical trials. Therefore, the role of CAC imaging in primary prevention of cardiovascular disease is somewhat contentious. Advocates for expanded CAC testing offer the large amount of observational data as support for their position, while opponents to wider CAC testing propose that only a clinical trial can resolve the matter. This paper reviews the arguments for and against such a trial based on clinical, safety and economic considerations. We also propose potential trial approaches based on recent changes in clinical practice that could make a new CAC trial design feasible.
authors.affiliation: Division of Cardiology and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, Maryland. Electronic address: jmcevoy1@jhmi.edu.
authors.forename: John W
authors.initials: JW
authors.lastname: McEvoy
authors.affiliation: Division of Cardiology and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Seth S
authors.initials: SS
authors.lastname: Martin
authors.affiliation: Division of Cardiology and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Blaha
authors.affiliation: Section of Cardiology, Department of Medicine, University of Chicago Medical Center, Chicago, Illinois.
authors.forename: Tamar S
authors.initials: TS
authors.lastname: Polonsky
authors.affiliation: Division of Cardiology and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, Maryland; Center for Healthcare Advancement and Outcomes and Miami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, Florida; Department of Medicine, Herbert Wertheim College of Medicine, and Department of Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida.
authors.forename: Khurram
authors.initials: K
authors.lastname: Nasir
authors.affiliation: Division of Cardiology, Cedars-Sinai Medical Center, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Kaul
authors.affiliation: Departments of Preventive Medicine and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Philip
authors.initials: P
authors.lastname: Greenland
authors.affiliation: Division of Cardiology and Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Roger S
authors.initials: RS
authors.lastname: Blumenthal
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D000072226:Computed Tomography Angiography / Q000009:adverse effects; D017023:Coronary Angiography / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging*; D019317:Evidence-Based Medicine; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D061205:Vascular Calcification / Q000000981:diagnostic imaging*
keywords: coronary artery calcification; outcomes; randomized controlled trial