Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

NCT01436773 | Completed DMC

• 1 other identifier: CVV-ACE-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Carotid Artery Adventitial Vaso Vasorum Density

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

  Measured within 1 week of enrollment.

Study Arms (3)

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Flordeliza Villanueva, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 20, 2011
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (1)