Abstract
BackgroundEpicardial adipose tissue (EAT) is a newly discovered independent risk factor for coronary atherosclerosis. There is a scarcity of information on the reduction of EAT volume to reduce atherosclerosis risk. Coronary computed tomography angiography (CCTA) has emerged as a noninvasive imaging method for the analysis of coronary atherosclerosis and EAT volume. The purpose of this trial is to determine whether olmesartan medoxomil is effective at both treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.Methods/designThis study is a prospective, single-center, open-label, randomized controlled clinical trial aimed at exploring the efficacy of olmesartan medoxomil on coronary atherosclerosis and EAT. A total of 194 patients with coronary stenosis greater than 30 % and less than 70 % detected by CCTA will be randomly divided into olmesartan medoxomil or conventional antihypertensive medication groups (1:1 ratio). The primary outcome measures include coronary atherosclerosis progression and EAT volume reduction, as detected by CCTA at 12 months. The secondary outcome measures include the levels of blood lipids, glucose, high-sensitivity C-reactive protein, IL-6, monocyte chemotactic protein 1, TNF-α, matrix metalloproteinase 9, NO, endothelin 1, adiponectin, and leptin at baseline and after 6 and 12 months.DiscussionTreatments aimed at reducing EAT volume can eventually achieve an antiatherosclerotic effect. This is the first trial designed to explore the effect of olmesartan medoxomil on both coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.Trial registrationClinicalTrials.gov: NCT02360956.
Highlights
Epicardial adipose tissue (EAT) is a newly discovered independent risk factor for coronary atherosclerosis
This is the first trial designed to explore the effect of olmesartan medoxomil on both coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by Coronary computed tomography angiography (CCTA)
As studies show that EAT volume is associated with plaque progression and cardiovascular adverse events, treatments aimed at reducing EAT volume may achieve an antiatherosclerotic, preventive effect
Summary
There are ample CCTA studies exploring the progression of coronary atherosclerosis following pharmacological manipulation. This study will accomplish two goals: (1) it will explain the relationship between EAT volume and coronary atherosclerosis progression and (2) it will verify the effect of olmesartan medoxomil on EAT volume reduction and coronary atherosclerosis progression. Evidence that olmesartan medoxomil is effective on EAT volume reduction and coronary atherosclerosis progression would be very attractive to clinicians and patients. This may further contribute to the care of patients with coronary heart disease. Authors’ contributions YZ conceived the study and drafted this manuscript, and will conduct the CCTA examinations and image analysis.
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