Assessment of Coronary Plaque Composition
|ClinicalTrials.gov Identifier: NCT01581632|
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Atherosclerosis Endothelial Dysfunction Coronary Small Vessel Disease||Device: LipiScan/LipiScan IVUS||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Coronary Plaque Composition Using Near Infrared Spectroscopy During Inhibition of LpPLA2 Activity|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
- 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 [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581632
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amir Lerman, MD||Mayo Clinic|