Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01436773
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : July 24, 2017
Lantheus Medical Imaging
Information provided by (Responsible Party):
Flordeliza Villanueva, University of Pittsburgh

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
Coronary Artery Disease

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 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Carotid Artery Adventitial Vaso Vasorum Density [ Time Frame: Measured within 1 week of enrollment. ]
    Assessed with ultrasound contrast agent, Definity, from Lantheus Medical Imaging.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented coronary artery disease and/or recent acute coronary event who undergo left heart catheterization, and patients with history and previous testing that cannot rule out coronary artery disease and undergo elective left heart catheterization.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01436773

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Lantheus Medical Imaging
Principal Investigator: Flordeliza Villanueva, MD University of Pittsburgh

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 Identifier: NCT01436773     History of Changes
Other Study ID Numbers: CVV-ACE-01
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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