3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events.
研究概览
简要总结
Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of the dynamic vascular features of the plaques, in a unique spatial format using three orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature as viewed in various angles provides a realistic representation that is more easily appreciated. Inter-observer variability for individual plaques has been assessed and inter-observer variability and inter-scan variability (the analysis of multiple images from single patients in longitudinal studies) were dependent on plaque size, with larger plaques showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid plaque will provide added value for the depiction of the and quantification of intra-plaque blood vessel density by providing a true volumetric viewing area. This data will be correlated to the subsequent surgical specimens. The goal of the protocol is to investigate the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa vasorum using quantitative software analyses. The histology methods used for quantification of hemorrhage and vessel density analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects with known carotid artery disease will be included.
- •Subject must be able and willing to comply with study procedures and provide a signed and dated informed consent including consent for 3 year annual follow up.
- •Subjects will be screened by asking each study subject if they have known or suspected hypersensitivity to any of the components of Optison, blood, blood products of albumin. In addition, each study subject will be asked if they have a right to left or bi-directional or transient right to left cardiac shunts. If any of the above questions are answered in the positive, the patient will not be eligible for inclusion in the study.
排除标准
- •Female subjects of child bearing potential will be excluded.
- •The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
- •History of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
- •Has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
- •Has known right to left, bi-directional or transient right to left cardiac shunts.
- •Any known contra-indications as listed on the current Optison package insert.
结局指标
主要结局
Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events.
时间窗: Post processing of CEUS will be done up to 3 years post surgery
Post processing of CEUS data for carotid plaque vascularization. In addition all carotid artery histology specimens, routinely obtained at the time of surgery at each center, will be analyzed to include the following tissue stains: CD3, CD31, CD38 and Hemosiderin.
次要结局
未报告次要终点
研究者
Diana Gaitini MD.
Director Ultrasound Unit, Dept of Medical Imaging
Rambam Health Care Campus