A Phase 1 interventional study of LipiScan/LipiScan IVUS in Coronary Atherosclerosis, Endothelial Dysfunction and Coronary Small Vessel Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science
The investigators' hypothesis is that local activation of the endogenous Lipoprotein-associated phospholipase A2 (Lp-PLA2) plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, this study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
The present study will be a substudy of our National Institute of Health (NIH) funded and Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary endothelial function.
The substudy will allow the investigators to also examine the additional endpoint of lipid core content of atherosclerotic plaques and hence plaque vulnerability. Plaque lipid composition will be measured using the LipiScan or LipiScan IVUS catheter (InfraReDx Near Infrared Spectroscopy (NIRS) System with or without intravascular ultrasound (IVUS) capability) at baseline and again at 6 month following Lp-PLA2 inhibition.
The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.
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This study's enrollment of 39 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
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Exclusion Criteria:
valuation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.
Device: LipiScan/LipiScan IVUS
Evaluation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.
Change from baseline of lipid plaque content measurement in the coronary artery
Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor, we will evaluate whether: 1. Plaque lipid content correlates with Lp-PLA2 levels and endothelial function 2. Lp-PLA2 inhibition reduced coronary plaque lipid content
Time frame: baseline and 6 month evaluation
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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