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临床试验/NCT01436773
NCT01436773已完成不适用

Identification of Carotid Vasa Vasorum and Correlation With Acute Coronary Events

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Carotid Artery Adventitial Vaso Vasorum Density

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Carotid Artery Adventitial Vaso Vasorum Density

时间窗: Measured within 1 week of enrollment.

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

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

研究点 (1)

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