Impact of coronary plaque geometry on plaque vulnerability and its association with the risk of future cardiovascular events in patients with chest pain undergoing coronary computed tomographic angiography—the GEOMETRY study: Protocol for a prospective clinical trial

INTRODUCTION: Coronary computed tomography angiography (CCTA) has emerged as a valuable noninvasive imaging tool for assessing atheromatous plaque morphology and composition, and several CCTA features have been validated as reliable indicators of the plaque-associated risk. However, the role of lesion geometry as a CCTA feature of plaque vulnerability has not been investigated so far. MATERIAL AND METHODS: Here we present the study protocol of the GEOMETRY trial, a prospective, single center, cohort study in which we aim to investigate the relationship between plaque geometry (as expressed by cross-sectional and longitudinal plaque eccentricity) and the risk for major adverse cardiac events (MACE) during 2 years of follow-up, in order to validate plaque eccentricity as a new CCTA marker of coronary plaque vulnerability. One thousand patients with suspected coronary artery disease (CAD) and pretest probability of CAD between 15% and 85%, who undergo CCTA and in whom CCTA identifies the presence of at least 1 significant coronary plaque (producing a luminal narrowing of at least 50%) will be enrolled in the study. Based on the results of complex image post-processing and plaque analysis, patients will be divided into 2 groups: group 1—patients in whom CCTA analysis identifies only non-eccentric coronary plaque; and group 2—patients in whom CCTA analysis reveals the presence of at least 1 eccentric significant coronary plaque producing a significant luminal narrowing. Study outcomes will consist in the rate of major cardiovascular events and the rate of plaque progression during follow-up. The study is funded by the Romanian Ministry of European Funds, the Romanian Government and the European Union, as part of the research grant number 103544/2016 – PlaqueIMAGE (contract number 26/01.09.2016). CONCLUSION: In conclusion, GEOMETRY will be the first CCTA-based study that will investigate the impact of geometric distribution of coronary atheromatous plaque on the future risk of cardiovascular events and on the rate of plaque progression, introducing and validating a new potential feature of plaque vulnerability represented by plaque geometry.