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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

March 15, 2012
August 20, 2014
January 2010
May 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01581632 on ClinicalTrials.gov Archive Site
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Assessment of Coronary Plaque Composition
Assessment of Coronary Plaque Composition Using Near Infrared Spectroscopy During Inhibition of LpPLA2 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, our 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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Coronary Atherosclerosis
  • Endothelial Dysfunction
  • Coronary Small Vessel Disease
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2015
May 2015   (final data collection date for primary outcome measure)

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
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
 
NCT01581632
09-007004
Yes
Amir Lerman, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Amir Lerman, MD Mayo Clinic
Mayo Clinic
August 2014

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