Clinical trial NCT03335020: Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease
Official title: 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...
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Fibromuscular Dysplasia of Arteries
Segmental Arterial Mediolysis
Spontaneous Coronary Artery Dissection
Atherosclerosis of Artery
Keywords: Ultrasound
3D ultrasonography
Contrast-enhanced ultrasound
Shear wave elastography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects who Completed All of the Ultrasound Examinations
timeFrame: 2 years after starting enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew W Urban
role: PRINCIPAL_INVESTIGATOR
References: