Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01436773
Collaborator
Lantheus Medical Imaging (Industry)
66
1
36
1.8

Study Details

Study Description

Brief Summary

Adventitial vasa vasorum (VV) as well as intraplaque microvessels are known to be associated with atherosclerotic plaque vulnerability. Contrast-enhanced ultrasound has been validated as a technique to measure the density of VV. Previous studies have demonstrated a relationship between identification of VV and relationship to vascular events such as stroke and myocardial infarction. No previous study has reported the utilization of contrast-enhanced ultrasound identification of VV in the carotid bed as a means of identifying patients at high risk for acute coronary events.

Aims: In this study, the investigators will aim to identify VV and intraplaque microvessels along with carotid intima media thickness (CIMT), a known marker for acute coronary events. The investigators will attempt to measure the correlation of VV with acute coronary events independent of traditional cardiovascular disease (CVD) risk factors and CIMT.

Methods: 90 volunteers (30 low risk patients, 30 patients with established coronary artery disease (CAD), and 30 patients with recent acute coronary syndrome (ACS)) will be enrolled. All patients will undergo contrast-enhanced ultrasound imaging of their carotid arteries and measurement of CIMT while obtaining baseline histories and assessment of traditional risk factors for coronary artery disease. VV density and CIMT will be measured in all patients. Statistical differences in VV among the three groups will be assessed and analyses will be made to attempt to identify if VV in the carotid bed is an independent predictor of acute coronary events after controlling for CIMT and traditional risk factors.

Study population: The study population will reflect the patient population of UPMC. No individual will be excluded on the basis of race, gender, or ethnicity.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    66 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events
    Study Start Date :
    May 1, 2009
    Actual Primary Completion Date :
    May 1, 2012
    Actual Study Completion Date :
    May 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Recent Acute Coronary Event

    Patients admitted to the hospital for recent STEMI or NSTEMI.

    Stable Coronary Artery Disease

    Patients with known Coronary Artery Disease without recent acute coronary event.

    No Coronary Artery Disease

    Patients with no evidence of coronary artery disease, assessed by coronary angiography.

    Outcome Measures

    Primary Outcome Measures

    1. Carotid Artery Adventitial Vaso Vasorum Density [Measured within 1 week of enrollment.]

      Assessed with ultrasound contrast agent, Definity, from Lantheus Medical Imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Individuals referred for elective left heart catheterization in the past three months or individuals who have undergone recent left heart catheterization for acute coronary syndrome in the past 3 months
    Exclusion Criteria:
    • Inability to provided informed consent

    • Pregnancy or of lack confirmed urine or serum B-hcg testing in pre-menopausal women under the age of 50

    • Known allergy to Definity (registered trademark)

    • Contraindications to Definity including permanent or transient right to left or bidirectional cardiac shunts, allergy to perflutren, severe pulmonary hypertension

    • Known cocaine abuse within the past year

    • History of heart transplantation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • Lantheus Medical Imaging

    Investigators

    • Principal Investigator: Flordeliza Villanueva, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Flordeliza Villanueva, Professor of Medicine, University of Pittsburgh School of Medicine; Vice Chair for Pre-Clinical Research, Department of Medicine; Director, Non Invasive Cardiac Imaging; Director, Center for Ultrasound Molecular Imaging and Therapeutics, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01436773
    Other Study ID Numbers:
    • CVV-ACE-01
    First Posted:
    Sep 20, 2011
    Last Update Posted:
    Jul 24, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 24, 2017