Assessment of Coronary Plaque Composition

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01581632
First received: March 15, 2012
Last updated: August 20, 2014
Last verified: August 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, our 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: LipiScan/LipiScan IVUS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Coronary Plaque Composition Using Near Infrared Spectroscopy During Inhibition of LpPLA2 Activity

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change from baseline of lipid plaque content measurement in the coronary artery [ Time Frame: baseline and 6 month evaluation ] [ Designated as safety issue: No ]
    Following recruitment of the total study population and 6-months therapy with the Lp-PLA2 inhibitor, we will evaluate whether: 1. Plaque lipid content correlates with Lp-PLA2 levels and endothelial function 2. Lp-PLA2 inhibition reduced coronary plaque lipid content


Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LipiScan/LipiScan IVUS
    Evaluation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.
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.

The substudy will allow the investigators to also examine the additional endpoint of lipid core content of atherosclerotic plaques and hence plaque vulnerability. Plaque lipid composition will be measured using the LipiScan or LipiScan IVUS catheter (InfraReDx NIRS(Near Infrared Spectroscopy) System with or without IVUS (Intra Vascular Ultrasound) capability) 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:

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

Exclusion Criteria:

  • 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
  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: NCT01581632

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: Amir Lerman, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Amir Lerman, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01581632     History of Changes
Other Study ID Numbers: 09-007004
Study First Received: March 15, 2012
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
atherosclerosis
endothelial dysfunction
coronary vasospasm

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

ClinicalTrials.gov processed this record on October 21, 2014