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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335020
Recruitment Status : Withdrawn (Closed by Investigator)
First Posted : November 7, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew W. Urban, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Number of Subjects who Completed All of the Ultrasound Examinations [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease
Official Title  ICMJE 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...
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Fibromuscular Dysplasia of Arteries
  • Segmental Arterial Mediolysis
  • Spontaneous Coronary Artery Dissection
  • Atherosclerosis of Artery
Intervention  ICMJE
  • Device: Shear Wave Elastography
    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.
    Other Name: Verasonics
  • Device: Pulse Wave Imaging
    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.
    Other Name: Verasonics
  • Drug: Contrast-Enhanced Ultrasound
    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.
    Other Name: Lumason
  • Other: Strain Imaging
    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.
  • Device: 3-D Volume Ultrasound
    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
Study Arms  ICMJE
  • Placebo Comparator: Normal
    Healthy volunteers. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
    Interventions:
    • Device: Shear Wave Elastography
    • Device: Pulse Wave Imaging
    • Drug: Contrast-Enhanced Ultrasound
    • Other: Strain Imaging
    • Device: 3-D Volume Ultrasound
  • Active Comparator: 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
    Interventions:
    • Device: Shear Wave Elastography
    • Device: Pulse Wave Imaging
    • Drug: Contrast-Enhanced Ultrasound
    • Other: Strain Imaging
    • Device: 3-D Volume Ultrasound
  • Active Comparator: Atherosclerosis
    Subjects with diagnosis of atherosclerosis. Assessment using Shear Wave Elastography, Pulse Wave Imaging, Contrast-Enhanced Ultrasound, Strain Imaging and 3-D Volume ultrasound
    Interventions:
    • Device: Shear Wave Elastography
    • Device: Pulse Wave Imaging
    • Drug: Contrast-Enhanced Ultrasound
    • Other: Strain Imaging
    • Device: 3-D Volume Ultrasound
  • Active Comparator: 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
    Interventions:
    • Device: Shear Wave Elastography
    • Device: Pulse Wave Imaging
    • Drug: Contrast-Enhanced Ultrasound
    • Other: Strain Imaging
    • Device: 3-D Volume Ultrasound
  • Active Comparator: 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
    Interventions:
    • Device: Shear Wave Elastography
    • Device: Pulse Wave Imaging
    • Drug: Contrast-Enhanced Ultrasound
    • Other: Strain Imaging
    • Device: 3-D Volume Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
250
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335020
Other Study ID Numbers  ICMJE 17-000020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew W. Urban, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew W Urban Mayo Clinic
PRS Account Mayo Clinic
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP