Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease
- Conditions
- Atherosclerosis of ArterySegmental Arterial MediolysisSpontaneous Coronary Artery DissectionFibromuscular Dysplasia of Arteries
- Interventions
- Device: Shear Wave ElastographyDevice: Pulse Wave ImagingDrug: Contrast-Enhanced UltrasoundOther: Strain ImagingDevice: 3-D Volume Ultrasound
- Registration Number
- NCT03335020
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Aims, purpose, or objectives:
1. 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).
2. 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.
3. 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.
4. 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fibromuscular Dysplasia (FMD) Pulse Wave Imaging Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Segmental Arterial Mediolysis (SAM) Contrast-Enhanced Ultrasound Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Fibromuscular Dysplasia (FMD) Strain Imaging Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Atherosclerosis Pulse Wave Imaging Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Atherosclerosis 3-D Volume Ultrasound Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Spontaneous Coronary Artery Dissection (SCAD) Pulse Wave Imaging Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Normal Contrast-Enhanced Ultrasound Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Normal Strain Imaging Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Fibromuscular Dysplasia (FMD) Shear Wave Elastography Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Atherosclerosis Shear Wave Elastography Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Normal Shear Wave Elastography Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Spontaneous Coronary Artery Dissection (SCAD) Strain Imaging Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Normal Pulse Wave Imaging Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Normal 3-D Volume Ultrasound Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Fibromuscular Dysplasia (FMD) Contrast-Enhanced Ultrasound Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Fibromuscular Dysplasia (FMD) 3-D Volume Ultrasound Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Atherosclerosis Contrast-Enhanced Ultrasound Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Spontaneous Coronary Artery Dissection (SCAD) 3-D Volume Ultrasound Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Segmental Arterial Mediolysis (SAM) Shear Wave Elastography Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Atherosclerosis Strain Imaging Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Spontaneous Coronary Artery Dissection (SCAD) Shear Wave Elastography Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Spontaneous Coronary Artery Dissection (SCAD) Contrast-Enhanced Ultrasound Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Segmental Arterial Mediolysis (SAM) 3-D Volume Ultrasound Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Segmental Arterial Mediolysis (SAM) Pulse Wave Imaging Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound Segmental Arterial Mediolysis (SAM) Strain Imaging Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
- Primary Outcome Measures
Name Time Method Number of Subjects who Completed All of the Ultrasound Examinations 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States