Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease

Mayo Clinic

Status and phase: Withdrawn; Phase 1

Conditions: Segmental Arterial Mediolysis; Atherosclerosis of Artery; Spontaneous Coronary Artery Dissection; Fibromuscular Dysplasia of Arteries

Treatments: Other: Strain Imaging; Device: Pulse Wave Imaging; Drug: Contrast-Enhanced Ultrasound; Device: 3-D Volume Ultrasound; Device: Shear Wave Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT03335020

17-000020

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 5 patient groups, including a placebo group

Normal

Placebo Comparator group

Description:

Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound

Treatment:

Device: Shear Wave Elastography

Other: Strain Imaging

Device: 3-D Volume Ultrasound

Drug: Contrast-Enhanced Ultrasound

Device: Pulse Wave Imaging

Fibromuscular Dysplasia (FMD)

Active Comparator group

Description:

Subjects with diagnosis of FMD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound

Treatment:

Device: Shear Wave Elastography

Other: Strain Imaging

Device: 3-D Volume Ultrasound

Drug: Contrast-Enhanced Ultrasound

Device: Pulse Wave Imaging

Atherosclerosis

Active Comparator group

Description:

Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound

Treatment:

Device: Shear Wave Elastography

Other: Strain Imaging

Device: 3-D Volume Ultrasound

Drug: Contrast-Enhanced Ultrasound

Device: Pulse Wave Imaging

Spontaneous Coronary Artery Dissection (SCAD)

Active Comparator group

Description:

Subjects with diagnosis of SCAD. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound

Treatment:

Device: Shear Wave Elastography

Other: Strain Imaging

Device: 3-D Volume Ultrasound

Drug: Contrast-Enhanced Ultrasound

Device: Pulse Wave Imaging

Segmental Arterial Mediolysis (SAM)

Active Comparator group

Description:

Subjects with diagnosis of SAM. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound

Treatment:

Device: Shear Wave Elastography

Other: Strain Imaging

Device: 3-D Volume Ultrasound

Drug: Contrast-Enhanced Ultrasound

Device: Pulse Wave Imaging