Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Recent Acute Coronary Event

Patients admitted to the hospital for recent STEMI or NSTEMI.

No interventions assigned to this group

Stable Coronary Artery Disease

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

No interventions assigned to this group

No Coronary Artery Disease

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR