New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Completed All of the Ultrasound Examinations
研究概览
简要总结
The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.
详细描述
All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Subject has carotid plaque with > 50% stenosis
- •Subject is able to understand the study procedure and provide informed consent
排除标准
- •Subject is pregnant or breast feeding
- •Subject is unable to provide informed consent
- •Subject has contraindication to the use of the Lumason contrast agent.
研究组 & 干预措施
Carotid Plaques with >70% Stenosis
Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Contrast-enhanced ultrasound (Combination Product)
Carotid Plaques with >70% Stenosis
Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Shear Wave Elastography (Device)
Carotid Plaques with >70% Stenosis
Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a > 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Ultrasound Examination (Device)
Carotid Plaques with 50-69% Stenosis
Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Contrast-enhanced ultrasound (Combination Product)
Carotid Plaques with 50-69% Stenosis
Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Shear Wave Elastography (Device)
Carotid Plaques with 50-69% Stenosis
Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.
干预措施: Ultrasound Examination (Device)
结局指标
主要结局
Number of Subjects Who Completed All of the Ultrasound Examinations
时间窗: 1 year after recruitment
Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).
次要结局
未报告次要终点
研究者
Matthew W. Urban
Principal Investigator
Mayo Clinic