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
  Purpose

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.


Condition Intervention
Coronary Atherosclerosis
Endothelial Dysfunction
Coronary Small Vessel Disease
Device: Optical Coherence Tomography (C7 XR Dragonfly )

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lp-PLa2 Activity

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642173

Contacts
Contact: Cindy M Woltman, RN 507-266-4095 woltman.cindy@mayo.edu
Contact: Lynn E Polk, RN 507-255-2527 polk.lynn@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Rajiv Gulati, MD         
Sponsors and Collaborators
Mayo Clinic
GlaxoSmithKline
Investigators
Principal Investigator: Rajiv Gulati, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Rajiv Gulati, MD Principal Investitgator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01642173     History of Changes
Other Study ID Numbers: 10-005460
Study First Received: June 26, 2012
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on September 16, 2014