Clinical trial NCT01642173: Assessment of Coronary Plaque Composition Using Optical Coherence Tomography
Official title: Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Atherosclerosis
Endothelial Dysfunction
Coronary Small Vessel Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-07-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of plaque vulnerability.
timeFrame: change from baseline to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rajiv Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References: