A Phase 1 interventional study of Shear Wave Elastography and Pulse Wave Imaging in Fibromuscular Dysplasia of Arteries, Segmental Arterial Mediolysis and Spontaneous Coronary Artery Dissection, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-29.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Basic science
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Among 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Coronary Artery Dissection, Spontaneous · United States.
Among the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States, this one is the only one that started in 2018, is the only one in phase 1, and was the 5th registered.
28 studies on the registry are indexed under Coronary Artery Dissection, Spontaneous; 18 are open to participants now.
Browse Coronary Artery Dissection, Spontaneous studies →8 of the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States are open now. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Ages 21–65
Vanderbilt University Medical Center · Sites in United States
Ages 18–100
Mayo Clinic · Sites in United States
Ages 18+ · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Coronary Artery Dissection, Spontaneous studies recruiting now, 11 (85%) set no upper age limit and 1 (8%) stops at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 1 started in 2018.
Median enrollment 28 across the 3 interventional studies, 675 across the 10 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 13 has an industry lead sponsor. The 6 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 8 studies filed under Coronary Artery Dissection, Spontaneous — fewer than ten, so there is no comparison to draw.
5 of the studies in Coronary Artery Dissection, Spontaneous with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04496687SCAD AllianceInternational Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry | 2026-12-31 |
| NCT07529691Vanderbilt University Medical CenterSurvey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia | 2027-04-30 |
| NCT05699200Mayo ClinicA Study to Analyze the Role of Sympathetic Nervous System in Spontaneous Coronary Artery Dissection | 2027-08 |
| NCT07526766Mayo ClinicA Study Of Exercise In Patients With Spontaneous Coronary Artery Dissection And Fibromuscular Dysplasia | 2027-08-30 |
| NCT07178509Mayo ClinicA Study of SCAD Using Stress Contrast Echocardiography | 2027-09 |
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Among the 13 studies in Coronary Artery Dissection, Spontaneous with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Aims, purpose, or objectives:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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
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
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.
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
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)
Time frame: 2 years after starting enrollment
Plan to share: No
Started Apr 2018 (actual). Primary completion is estimated for Dec 2020, 32 months after the start.
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This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Coronary Artery Dissection, Spontaneous →