Completed

NCT Number: NCT01642173

Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

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.

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Key information

Conditions

Coronary Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Small Vessel Disease Endothelial Dysfunction Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

The present study was 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 Lp-PLA2 activity and improvement in coronary endothelial function.

This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age > 18 years and < 85 years
referred to our cardiac catheterization laboratory for coronary vasomotion testing
are found to have coronary endothelial dysfunction.

Exclusion criteria

these include heart failure
ejection fraction < 40%
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
Federal Medical Center inmates

Treatment and study plan

Optical Coherence Tomography (C7 XR Dragonfly )

Device

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.

Other names: C7 XR Dragonfly Optical Coherence Tomography system

Primary outcomes

Quantification of plaque vulnerability.

Time frame: change from baseline to six months

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

GlaxoSmithKline

Registry information

Official study title

Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jul 17, 2012
Registry last updated: Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed