NCT01642173|CompletedPhase 1DMC
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Sponsor study identifier
interventional
41
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)The investigator's hypothesis is that local activation of the endogenous 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, the investigators 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.
June 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.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 26, 2012
Actual (reported)July 17, 2012
Actual (reported)June 2015
Actual (reported)June 2015
Actual (reported)Quantification of plaque vulnerability.
Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor or placebo, using Optical Coherence Tomography (OCT) we will quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content comparing baseline and 6 months studies.
change from baseline to six months
Subjects enrolled in the NIH funded and IRB approved (08-008161) protocol "Lp-PLA2 and Coronary Atherosclerosis in Humans" with a positive diagnosis of coronary artery endothelial dysfunction will be studied using Optical Coherence Tomography during the angiogram at baseline.
Subjects who are enrolled in IRB 10-000044 "Lp-PLA2 and Coronary Atherosclerosis in Humans Aim III" a study in which the investigators are examining the impact of long-term inhibition of Lp-PLA2, with a specific novel inhibitor or placebo, on Lp-PLA2 activity and improvement in coronary endothelial function will be studied using Optical Coherence Tomography during the 6 month return angiogram.
Evaluation of the coronary artery using Optical Coherence Tomography utilizing the Dragonfly OCT catheter following a clinically indicated angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLa2 inhibition or placebo.
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
Rajiv Gulati, MD
Mayo Clinic
41 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2012
First Posted
July 17, 2012
Study Start
October 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
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
October 3, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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