Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Coronary Small Vessel Disease; Endothelial Dysfunction; Coronary Atherosclerosis

Treatments: Device: Optical Coherence Tomography (C7 XR Dragonfly )

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01642173

10-005460

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

OCT at baseline

Other group

Description:

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.

Treatment:

Device: Optical Coherence Tomography (C7 XR Dragonfly )

OCT following 6 month Lp-PLa2 inhibition

Other group

Description:

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.

Treatment:

Device: Optical Coherence Tomography (C7 XR Dragonfly )