NCT01581632|CompletedPhase 1DMC
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Sponsor study identifier
interventional
39
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 15, 2012
Actual (reported)April 20, 2012
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)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
baseline and 6 month evaluation
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mayo Clinic
Rochester, Minnesota, 55905, United States
Amir Lerman, MD
Mayo Clinic
39 participants (actual enrollment reported by the registry).
First Submitted
March 15, 2012
First Posted
April 20, 2012
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
March 5, 2019
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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