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

NCT03335020 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: 17-000020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects who Completed All of the Ultrasound Examinations

  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)

  2 years after starting enrollment

Study Arms (5)

Normal

PLACEBO COMPARATOR

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

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

Fibromuscular Dysplasia (FMD)

ACTIVE COMPARATOR

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

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

Atherosclerosis

ACTIVE COMPARATOR

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

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

Spontaneous Coronary Artery Dissection (SCAD)

ACTIVE COMPARATOR

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

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

Segmental Arterial Mediolysis (SAM)

ACTIVE COMPARATOR

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

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

Interventions

Shear Wave Elastography DEVICE

The subject will be asked to lay on a hospital bed for ultrasound imaging of the arteries. The subject will have an automatic blood pressure cuff put on to measure blood pressure. The subject will also have a three-lead ECG taken during the experiment. The artery will be visualized using ultrasound imaging, and the depth of the arterial wall will be noted. The focal depth on the device will be set to measure shear wave propagation in the walls of the artery. Measurements will be made at multiple locations along the artery's length and at different phases of the cardiac cycle determined by ECG gating. Either or both the Verasonics or GE Logiq systems will be used for measurements. Measurements made with these systems use acoustic output within the FDA regulatory limits of diagnostic imaging.

Also known as: Verasonics

Atherosclerosis; Fibromuscular Dysplasia (FMD); Normal; Segmental Arterial Mediolysis (SAM); Spontaneous Coronary Artery Dissection (SCAD)

Pulse Wave Imaging DEVICE

Researchers will use the Verasonics device to acquire data for measurement of wave velocity in the tissue of interest (arterial walls and surrounding tissue) due to the pressure pulse from ejection of blood by the heart into the systemic circulation. Using ECG gating we can regulate the timing of the individual acquisitions. In each acquisition, high frame rate ultrasound imaging is used to acquire data to measure the motion of the propagating waves. Multiple measurements on different heartbeats are made with varying delays to obtain measurements throughout the heart cycle assuming at that the behavior during consecutive heartbeats is similar. Multiple measurements will be made in a given artery and multiple locations in the arterial wall.

Also known as: Verasonics

Atherosclerosis; Fibromuscular Dysplasia (FMD); Normal; Segmental Arterial Mediolysis (SAM); Spontaneous Coronary Artery Dissection (SCAD)

Contrast-Enhanced Ultrasound DRUG

Will be done using Lumason (Bracco Diagnostics, Inc) administered intravenously via slow hand infusion. Real-time contrast-enhanced carotid cine-loop (longitudinal and short axis) images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the determined artery will be acquired and digitally stored for off line analysis. Up to two vials will be used for a study.

Also known as: Lumason

Atherosclerosis; Fibromuscular Dysplasia (FMD); Normal; Segmental Arterial Mediolysis (SAM); Spontaneous Coronary Artery Dissection (SCAD)

Strain Imaging OTHER

Measurements will be performed offline on the workstation using Echo PAC software (GE Healthcare Inc., Princeton, NJ). The media-adventitia interface of the arterial wall will be manually traced from a still frame image. The circumferential and radial strain curves will be automatically obtained. Measurements of the peak radial and circumferential strain, strain rate will be obtained. If arterial plaque is identified: A region of interest will be placed at the plaque in 3 different regions: 2 shoulder regions and the fibrous cap top, the measurement results of the peak longitudinal, radial and circumferential strain, strain rate will be acquired by the software.

Atherosclerosis; Fibromuscular Dysplasia (FMD); Normal; Segmental Arterial Mediolysis (SAM); Spontaneous Coronary Artery Dissection (SCAD)

3-D Volume Ultrasound DEVICE

When generating a 3D volume the ultrasound data can be collected in 4 common ways. Freehand, which involves tilting the probe and capturing a series of ultrasound images and recording the transducer orientation for each slice. Mechanically, where the internal linear probe tilt is handled by a motor inside the probe. Using an endoprobe, which generates the volume by inserting a probe and then removing the transducer in a controlled manner. The fourth technology is the matrix array transducer that uses beam steering to sample points throughout a pyramid shaped volume

Atherosclerosis; Fibromuscular Dysplasia (FMD); Normal; Segmental Arterial Mediolysis (SAM); Spontaneous Coronary Artery Dissection (SCAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fibromuscular Dysplasia; Coronary Artery Dissection, Spontaneous

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew W Urban

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 7, 2017
• Study Start: April 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)