Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rajiv Gulati, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01642173
First received: June 26, 2012
Last updated: March 26, 2014
Last verified: March 2014

June 26, 2012
March 26, 2014
October 2010
January 2015   (final data collection date for primary outcome measure)
Quantification of plaque vulnerability. [ Time Frame: change from baseline to six months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01642173 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lp-PLa2 Activity

The investigators 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.

The present study will be 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 LpPLA2 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 month 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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Atherosclerosis
  • Endothelial Dysfunction
  • Coronary Small Vessel Disease
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.
Other Name: C7 XR Dragonfly Optical Coherence Tomography system
  • OCT at baseline
    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.
    Intervention: Device: Optical Coherence Tomography (C7 XR Dragonfly )
  • OCT following 6 month Lp-PLa2 inhibition
    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 LpPLA2 activity and improvement in coronary endothelial function will be studied using Optical Coherence Tomography during the 6 month return angiogram.
    Intervention: Device: Optical Coherence Tomography (C7 XR Dragonfly )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Cindy M Woltman, RN 507-266-4095 woltman.cindy@mayo.edu
Contact: Lynn E Polk, RN 507-255-2527 polk.lynn@mayo.edu
United States
 
NCT01642173
10-005460
Yes
Rajiv Gulati, Mayo Clinic
Mayo Clinic
GlaxoSmithKline
Principal Investigator: Rajiv Gulati, MD Mayo Clinic
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP