Active — Not RecruitingPhase 4

Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound

United States20 participantsStarted 2020-12-01

Plain-language summary

This is an open-label, non-randomized study conducted at Thomas Jefferson University comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. There is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. This pressure estimation technique (referred as SHAPE) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients \>18 years old and willing and able to participate. Patients with atherosclerosis scheduled for carotid endarterectomy Exclusion Criteria: * • Pregnancy or breast-feeding at the time of the scan * Patients with known hypersensitivity or allergy to any component (including perflutren) of Definity (Lantheus Medical Imaging, Billerica, MA). * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: * Patients on life support or in a critical care unit. * Patients with unstable occlusive disease (e.g., crescendo angina). * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia. * Patients with uncontrolled congestive heart failure (NYHA Class IV). * Patients with recent cerebral hemorrhage. * Patients who have undergone surgery within 24 hours prior to the study sonographic examination. * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) or respiratory distress syndrome. * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli. * Patients who have received any contrast medium (X-ray, MRI, CT or ultrasound) in the 24 hours prior to the research ultrasound exam

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between the pressure gradient and surrogate (imaging and histological) predictors

Timeframe: pre-endarterectomy

Trial details

NCT IDNCT04643431

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-05

View on ClinicalTrials.gov More Carotid Atherosclerosis trials