BACKGROUND: Carotid intima-media thickness (CIMT) measurements have been widely used as primary endpoint in studies into the effects of new interventions as alternative for cardiovascular morbidity and mortality. There are no accepted standards on the use of CIMT measurements in intervention studies and choices in the design and analysis of a CIMT study are generally based on experience and expert opinion. In the present review, we provide an overview of the current evidence on several aspects in the design and analysis of a CIMT study on the early effects of new interventions. SUMMARY OF ISSUES: A balanced evaluation of the carotid segments, carotid walls, and image view to be used as CIMT study endpoint; the reading method (manual or semi-automated and continuously or in batch) to be employed, the required sample size, and the frequency of ultrasound examinations is provided. We also discuss the preferred methods to analyse longitudinal CIMT data and address the possible impact of, and methods to deal with missing and biologically implausible CIMT values. CONCLUSIONS: Linear mixed effects models are the preferred way to analyse CIMT data and do appropriately handle missing and biologically implausible CIMT values. Furthermore, we recommend to use extensive CIMT designs that measure CIMT at regular points during the multiple carotid sites as such approach is likely to increase the success rates of CIMT intervention studies designed to evaluate the effects of new interventions on atherosclerotic burden.
Atherosclerosis ; Carotid Intima-Media Thickness ; Expert Testimony ; Clinical Trial ; Sample Size ; Statistics as Topic