Assessment of Coronary Plaque Composition

NCT01581632 | Completed Phase 1 DMC

• 1 other identifier: 09-007004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' hypothesis is that local activation of the endogenous Lipoprotein-associated phospholipase A2 (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, this study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

Conditions

Coronary Atherosclerosis; Endothelial Dysfunction; Coronary Small Vessel Disease

Keywords

atherosclerosis; endothelial dysfunction; coronary vasospasm

Outcome Measures

Primary Outcomes (1)

• Change from baseline of lipid plaque content measurement in the coronary artery

  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

  baseline and 6 month evaluation

Study Arms (1)

LipiScan/LipiScan IVUS

OTHER

valuation 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.

Device: LipiScan/LipiScan IVUS

Interventions

LipiScan/LipiScan IVUS DEVICE

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.

LipiScan/LipiScan IVUS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Coronary Vasospasm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amir Lerman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: April 20, 2012
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 5, 2019

Record last verified: 2017-11

Locations

US (1)