2023-504573-20-00招募中2 期
PLAQUE AND BRAIN INFLAMMATION IN SYMPTOMATIC CAROTID STENOSIS: ROLE OF THE FICOLIN-2 STATEMENT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the correlation between: - Plasma levels of ficolin-2 at day 5, - Metabolic data on [18F]DPA-714 PET/MRI: standardized uptake value (SUV) and Logan distribution volume ratio (DVR) of [18F]DPA-714 in carotids and brain at the time of the PET-Scan imaging (day 5).
研究概览
简要总结
To assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on [18F]DPA-714 PET/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- [18f]dpa-714 Pet
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years or over, -Signed written informed consent before any study specific intervention, -Probable ipsilateral transient ischemic attack (TIA – which involve a focal speech/language, motor or visual deficit referable to the distribution of a carotid artery and lasting less than 48 hours from the onset) OR retinal artery occlusion ≤ 48h OR ischemic stroke ≤ 48h from the onset,- Atherosclerotic carotid stenosis between 50% and 99% (NASCET method), as confirmed by one of the imaging examinations (among: Doppler ultrasound, MR angiography, CT angiography, catheter angiography) performed after index TIA or ischemic stroke- - No other identified cause of TIA, ischemic stroke or retinal artery occlusion,
排除标准
- •Patients with inflammatory or autoimmune disease, hepatocellular insufficiency, acute or chronic infection, active malignancy, myocardial infarction or major surgery within the previous 30 days of index hospitalization according to the investigator, - Patients with severe renal insufficiency (estimated GFR < 30 ml/min at inclusion or known dialysis), - Patients with contraindication to MRI (agitation, claustrophobia, pacemaker, metallic (ferromagnetic) body, a known allergy to gadolinium) according to the investigator’s judgment, - Patients currently enrolled in another clinical trial including investigational medicinal products, - Female patient who is pregnant or lactating, or is of child-bearing and who did not agree to use highly effective methods of birth control throughout the study, - Patient without health coverage, - Patient under legal protection.
结局指标
主要结局
the correlation between: - Plasma levels of ficolin-2 at day 5, - Metabolic data on [18F]DPA-714 PET/MRI: standardized uptake value (SUV) and Logan distribution volume ratio (DVR) of [18F]DPA-714 in carotids and brain at the time of the PET-Scan imaging (day 5).
the correlation between: - Plasma levels of ficolin-2 at day 5, - Metabolic data on [18F]DPA-714 PET/MRI: standardized uptake value (SUV) and Logan distribution volume ratio (DVR) of [18F]DPA-714 in carotids and brain at the time of the PET-Scan imaging (day 5).
次要结局
- • Plasma levels of ficolin-2 at day 5 when correlating with morphological data and at day-15 when correlating with histological data, • Morphological data evaluated by the Central Image Reading Board at day 5: - on carotid plaque PET/MRI: presence of intraplaque hemorrhage, lipid-rich necrotic core, and thinning/rupture of the fibrous cap on carotid plaque MRI - on brain PET/MRI: infarct size, hemorrhagic transformation, and blood-brain barrier leakage evaluated by the Central Image Readin
研究者
Dr MECHTOUFF
Scientific
Hospices Civils De Lyon
研究点 (1)
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