Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2010-01-31
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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LipiScan/LipiScan IVUS
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* referred to our cardiac catheterization laboratory for coronary vasomotion testing- subsequently found to have coronary endothelial dysfunction.
Exclusion Criteria
* unstable angina
* myocardial infarction or angioplasty within 6 months prior to entry into the study
* use of investigational agents within 1 month of entry into the study
* patients who require treatment with positive inotropic agents other than digoxin during the study
* patients with cerebrovascular accident within 6 months prior to entry the study
* significant endocrine, hepatic or renal, disorders, local or systemic infectious disease within 4 weeks prior to entry into study
* pregnancy or lactation
* mental instability
18 Years
85 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Amir Lerman
Professor of Medicine
Principal Investigators
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Amir Lerman, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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09-007004
Identifier Type: -
Identifier Source: org_study_id
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