NCT03353103Unknown2 期
Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- carotid F18-NaF uptake
研究概览
简要总结
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
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
- •Age over 18 years old
- •Health care system affiliation
- •Referred to carotid endarterectomy
- •Symptomatic patients:
- •Carotid stenosis between 70 and 99% (NASCET criteria)
- •TIA or minor stroke attack (RANKIN ≤ 3)
- •Asymptomatic patients:
- •Carotid stenosis between 70 and 99% (NASCET criteria)
- •No symptoms
- •Patient who has been informed of the study and has given his/her informed consent
排除标准
- •Contra indication to MRI
- •Renal failure (clearance < 30ml/mn)
- •Patient with active inflammatory disease
- •History of cancer
- •Pregnancy or lactation
- •Patient with carotid disease treated by fibrinolysis
- •Patient under guardianship, or unable to understand the purpose of the study
研究组 & 干预措施
symptomatic
Active Comparator
干预措施: Sodium fluoride F-18 PET imaging (Drug)
asymptomatic
Active Comparator
干预措施: Sodium fluoride F-18 PET imaging (Drug)
结局指标
主要结局
carotid F18-NaF uptake
时间窗: baseline
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
次要结局
- F18-NaF PET uptake(baseline)
- comparaison of F18-NaF PET and Carotid MRI(baseline)
- histology(baseline)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)Carotid StenosisNCT03234257French Cardiology Society69
已完成
不适用
Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)Carotid Artery DiseasesCoronary Artery DiseaseAtherosclerosisNCT01178320University of Washington230
招募中
不适用
Atherosclerotic Plaque Imaging Project (CPIP)Atherosclerotic PlaqueAtherosclerosisNCT05821894Lund University3,500
招募中
不适用
Evaluation of the Vulnerable Carotid Atherosclerotic Plaque: A Clinical Multicenter StudyUltrasoundNCT05849909huang pintong57
已完成
不适用
Histological Validation Of Carotid Plaque Composition In Preoperative ImagingCarotid StenosisNCT01456403Lawson Health Research Institute95