Assessment of Coronary Plaque Composition
|Coronary Atherosclerosis Endothelial Dysfunction Coronary Small Vessel Disease||Device: LipiScan/LipiScan IVUS|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Assessment of Coronary Plaque Composition Using Near Infrared Spectroscopy During Inhibition of LpPLA2 Activity|
- Change from baseline of lipid plaque content measurement in the coronary artery [ Time Frame: baseline and 6 month evaluation ]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
|Study Start Date:||January 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Device: LipiScan/LipiScan IVUS
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 LpPLA2 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 NIRS(Near Infrared Spectroscopy) System with or without IVUS (Intra Vascular Ultrasound) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581632
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, MD||Mayo Clinic|