Assessment of Contrast-enhanced Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Arterial Wall Visualization and Stiffness in Patients With Fibromuscular Dysplasia...
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 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 see whether contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography improves arterial wall visualization and identifies arterial elastic properties among individuals with fibromuscular dysplasia (FMD), atherosclerosis, personal history of spontaneous coronary artery dissections (SCAD), or personal history of segmental arterial mediolysis (SAM) that may be different compared to those without the aforementioned conditions.
详细描述
Aims, purpose, or objectives:
- To describe whether contrast-enhanced ultrasonography, strain imaging, and 3-D volume ultrasonography are helpful to characterize affected arteries and improve the imaging of arterial wall among patients with Fibromuscular Dysplasia (FMD) and segmental arterial mediolysis (SAM).
- Evaluate the arterial elastic properties of individuals with FMD and compare to normal individuals, those with atherosclerosis disease, those with personal history of spontaneous coronary artery dissections (SCAD), and/or personal history of segmental arterial mediolysis (SAM) by elastography.
- Identification of vulnerable arterial elastic properties using contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography to predict short-term and long-term outcomes among individuals with FMD, normal individuals, those with atherosclerosis disease, those with SCAD, and/or SAM.
- Develop risk factor profiles and risk score systems of patients undergoing contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography among individuals with FMD, those with atherosclerosis disease, those with personal history of SCAD, and/or personal history of SAM.
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
- 是
入选标准
- •Diagnosis of fibromuscular dysplasia (FMD), and/or segmental arterial mediolysis (SAM), and/or spontaneous coronary artery dissection (SCAD), and those with atherosclerosis, and normal individuals.
- •Adult male and non-pregnant female patient 18-100 years of age.
- •Patients who are able and willing to sign the informed consent will be enrolled.
排除标准
- •Missing records to determine whether or not they have fibromuscular dysplasia (FMD), and/or segmental arterial mediolysis (SAM), and/or spontaneous coronary artery dissection (SCAD), and those with atherosclerosis, and normal individuals.
- •Patients who do not accept to participate in research studies.
- •Prior contraindication to contrast agent.
- •Women who are breastfeeding or pregnant
- •Patients less than 18 yo
研究组 & 干预措施
Normal
Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Shear Wave Elastography (Device)
Normal
Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Pulse Wave Imaging (Device)
Normal
Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Contrast-Enhanced Ultrasound (Drug)
Normal
Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Strain Imaging (Other)
Normal
Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: 3-D Volume Ultrasound (Device)
Fibromuscular Dysplasia (FMD)
Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Shear Wave Elastography (Device)
Fibromuscular Dysplasia (FMD)
Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Pulse Wave Imaging (Device)
Fibromuscular Dysplasia (FMD)
Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Contrast-Enhanced Ultrasound (Drug)
Fibromuscular Dysplasia (FMD)
Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Strain Imaging (Other)
Fibromuscular Dysplasia (FMD)
Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: 3-D Volume Ultrasound (Device)
Atherosclerosis
Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Shear Wave Elastography (Device)
Atherosclerosis
Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Pulse Wave Imaging (Device)
Atherosclerosis
Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Contrast-Enhanced Ultrasound (Drug)
Atherosclerosis
Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Strain Imaging (Other)
Atherosclerosis
Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: 3-D Volume Ultrasound (Device)
Spontaneous Coronary Artery Dissection (SCAD)
Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Shear Wave Elastography (Device)
Spontaneous Coronary Artery Dissection (SCAD)
Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Pulse Wave Imaging (Device)
Spontaneous Coronary Artery Dissection (SCAD)
Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Contrast-Enhanced Ultrasound (Drug)
Spontaneous Coronary Artery Dissection (SCAD)
Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Strain Imaging (Other)
Spontaneous Coronary Artery Dissection (SCAD)
Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: 3-D Volume Ultrasound (Device)
Segmental Arterial Mediolysis (SAM)
Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Shear Wave Elastography (Device)
Segmental Arterial Mediolysis (SAM)
Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Pulse Wave Imaging (Device)
Segmental Arterial Mediolysis (SAM)
Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Contrast-Enhanced Ultrasound (Drug)
Segmental Arterial Mediolysis (SAM)
Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: Strain Imaging (Other)
Segmental Arterial Mediolysis (SAM)
Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
干预措施: 3-D Volume Ultrasound (Device)
结局指标
主要结局
Number of Subjects who Completed All of the Ultrasound Examinations
时间窗: 2 years after starting enrollment
Completion of ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography, pulse wave imaging, strain imaging)
次要结局
未报告次要终点
研究者
Matthew W. Urban
Associate Professor of Biomedical Engineering
Mayo Clinic