Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events
|ClinicalTrials.gov Identifier: NCT01436773|
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : July 24, 2017
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|
|Official Title:||Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events|
|Study Start Date :||May 2009|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
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.
- Carotid Artery Adventitial Vaso Vasorum Density [ Time Frame: Measured within 1 week of enrollment. ]Assessed with ultrasound contrast agent, Definity, from Lantheus Medical Imaging.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436773
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Flordeliza Villanueva, MD||University of Pittsburgh|