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Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

NCT01642173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Coronary Atherosclerosis
  • Endothelial Dysfunction
  • Coronary Small Vessel Disease

Interventions

DEVICE

Optical Coherence Tomography (C7 XR Dragonfly )

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.

Sponsors & Collaborators

Principal Investigators

  • Rajiv Gulati, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642173 on ClinicalTrials.gov