Status:
COMPLETED
Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Supra-Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study, the investigator propose to determine the efficiency of a new and more sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at characterizing vulne...
Eligibility Criteria
Inclusion
- Male or female subjects of any ethnic background, aged \> 18 years
- Any of the following known or suspected supra-aortic arterial disease based on : Prior stroke; Transient Ischemic Attack; Amaurosis Fugax; Referred for evaluation of any supra-aortic vessel; Follow-up for a stent in a supra-aortic vessel; Prior imaging ultrasounds study showing \> ou = 50 % stenosis of a supra-aortic vessel segment (within 60 days before consent)
- Patient undergoing surgery within one month of carotid plaque evaluation
- Willingness and ability to follow directions and complete all study procedures specified in the protocol
- Pre-menopausal women only : Negative urinary pregnancy test on the day of imaging before the administration of study drug
- Patient has accepted to participate to the study and has signed the written consent
- Patient is affiliated to social security
Exclusion
- Contraindication to MRI examinations (e.g. inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, metallic devices not approved for MRI such as defibrillators, pacemaker, heart valve prostheses, cochlear implants, neuro-stimulators, implanted automated injection device, intraocular metallic foreign bodies, neurosurgical and vascular clips);
- Contraindication to the use of iodine and gadolinium containing contrast media (including subjects with suspicion for/or known to have NSF);- History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents (as judged by the investigator, taking into account the intensity of the event);
- Estimated Glomerular Filtration Rate (eGFR) value \< 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging;
- Any subject on hemodialysis or peritoneal dialysis (Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the examination should be used);
- Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the per-operative liver transplantation period;
- Known subject history of severe cardiovascular disease (e.g. acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome;
- Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery);
- Scheduled or potentially expected for the period between the SPCCT or DECT and MRI: Any procedure that may alter the MRI or CT interpretation; Any interventional or surgical procedure involving the supra-aortic vessels.
- Pregnant or nursing (including pumping for storage and feeding); 11. Patient under guardianship, curators or safeguard of justice.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04466787
Start Date
June 20 2019
End Date
November 24 2021
Last Update
July 15 2024
Active Locations (1)
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1
Louis Pradel cardiovascular Hospital
Bron, France