Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation.

Hospices Civils de Lyon1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2019年6月20日最近更新: 2024年7月15日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hospices Civils de Lyon
入组人数: 22
试验地点: 1
主要终点: Intra Plaque Hemorrhage (IPH) in mm² identified with DECT

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in current practice

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: Single (Outcomes Assessor)

盲法说明

The images will be read without knowing the CT scan used

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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);
•Patient under guardianship, curators or safeguard of justice.