跳至主要内容
临床试验/NCT02748941
NCT02748941招募中不适用

Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
77
试验地点
2
主要终点
ulceration or cap rupture présence in HR MRI

研究概览

简要总结

Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large arteries, mainly carotid, is involved in about 20% of cases.

After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography.

The composition of the plaque, showing its vulnerability, is associated with embolic risk and stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo the inflammation of the plaque, its embolic consequences or the mechanical stress it undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile (mi RNA). These different modalities must be combined in order to increase the efficiency.

Based on these encouraging results, the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability. Performance evaluation will allow us to choose secondarily the most relevant association.

The investigator propose, as a first step, to make a case-control study with these methods, the cases are patients who had an ischemic stroke (authenticated by both the clinical exam and brain MRI) on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke. This study is a cross-sectional study because it simultaneously measures the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque.

Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50% caliber constriction according to NASCET criteria. (North American Symptomatic Carotid Endarterectomy Trial).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Carotid stenosis ≥ 50% NASCET
  • Case: ipsilateral carotid stenosis stroke, certified by MRI or CT in the preceding month, with no others causes of stroke
  • Control: no clinical sign or MRI hint for a recent stroke
  • Signed informed consent form
  • Patient affiliated to a social security system or equivalent

排除标准

  • Modified Rankin scale > 3
  • Homolateral stroke or TIA > 1 month
  • Medical history of homolateral carotid surgery, cervical radiation, carotid occlusive, homolateral intracranial stenosis, risk of developing arterial thromboembolic events
  • Renal failure (creatinine clearance < 50 ml/min)
  • Contraindication to ultrasound (sonovue)
  • Contraindication to MRI and its contrast media (Gadolinium)
  • Inability to sign informed consent
  • Inability to undergo any of the technics (claustrophobia...)
  • Serious co-morbid disease, dementia
  • Neurological disease with no carotid disease
  • Risk of pregnancy or pregnancy or breastfeeding
  • Adult under reinforced guardianship or legal guardian
  • Patient not understanding French

结局指标

主要结局

ulceration or cap rupture présence in HR MRI

时间窗: Day 1

Number of HITS per hour in doppler ultrasonography

时间窗: Day 1

GSM (Gray Scale Median) quantification in doppler ultrasonography

时间窗: Day 1

Ulceration > 2 mm presence in doppler ultrasonography

时间窗: Day 1

hemorrhage intra-plaque présence in HR MRI

时间窗: Day 1

large lipid-rich necrotic core présence in HR MRI

时间窗: Day 1

CEUS (Contrast Enhanced UltraSound )

时间窗: Day 1

signal intensity amplification quantification and Ulceration \> 2 mm

次要结局

  • shear stresses (Pa) on the surface of the plaque(Day 1)
  • mi-RNA identification(Day 1)
  • large lipid-rich necrotic core(Day 1)
  • ulceration or cap rupture(Day 1)
  • hemorrhage intra-plaque(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Carotid Atherosclerosis : Innovative Imaging... | 临床试验