Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

NCT01642173 | Completed Phase 1 DMC

• 1 other identifier: 10-005460
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OCT at baseline

OTHER

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.

Device: Optical Coherence Tomography (C7 XR Dragonfly )

OCT following 6 month Lp-PLa2 inhibition

OTHER

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.

Device: Optical Coherence Tomography (C7 XR Dragonfly )

Interventions

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.

Also known as: C7 XR Dragonfly Optical Coherence Tomography system

OCT at baseline; OCT following 6 month Lp-PLa2 inhibition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Rajiv Gulati, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Principal Investitgator

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 17, 2012
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

US (1)