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临床试验/NCT04470687
NCT04470687已完成不适用

Innovative Applications of Ultrafast Ultrasound Imaging in Peripheral Vascular Pathology: Evaluation of Carotid Plaque Vulnerability by Quantification of Neovascularization

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Neovascularization of the carotid plaque

研究概览

简要总结

Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. Patients with stenosis over 70% are therefore offered an endarterectomy, an operation to remove carotid plaque, to prevent future strokes[1]. In asymptomatic patients, the degree of stenosis is a limited predictor, and better risk stratification is required to assess the degree of plaque vulnerability and stroke risk of the patient. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable and dependent benefit/risk balance for each patient. A number of imaging parameters have been studied: ulceration, heterogeneity, vascularization of the plaque for example, but their place is not well defined [2].

The usual evaluation of carotid stenosis is by conventional Doppler ultrasound with calculation of the degree of stenosis according to the NASCET criteria.

For symptomatic stenoses the intervention is recommended when above 70% and is discussed from 50% to 70% of NASCET stenosis degree.

For asymptomatic stenoses, the procedure is discussed when above 60% taking into account the patient's life expectancy, the risk of the surgery and the unstable nature of the plaque [2].

Destabilization of the carotid plaque is partially induced by inflammation associated with neo-vascularization. The detection of these new vessels by conventional contrast ultrasound has already shown a distinction between stable and unstable plaques, by the presence or absence of microbubbles in the plaque. However, this assessment is not very precise and only the most vascularized plaques can be detected. Ultrafast ultrasound Imaging is a new ultrasonic Imaging modality that allows detecting low speed flows, a tiny vascular structure within the vessel wall.

RESEARCH HYPOTHESIS Plaques neo-vascularization would be more precisely detected and characterized by ultrafast imaging coupled with microbubble injection than conventional ultrasound imaging.

A better assessment of plaque instability could improve the selection of patients for carotid endarterectomy and increase the benefit/risk ratio of this preventive surgery.

详细描述

see above

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

  • The patient is over 18
  • The patient is scheduled for carotid endarterectomy within 30 days at most
  • The patient has a social security system

排除标准

  • Non-atheromatous carotid stenosis (radiation)
  • Contraindication of the use of SonoVue ultrasound contrast media. Hypersensitivity to the active ingredient or any of the following excipients: Macrogol 4000; Distearoylphosphatidylcholine; Dipalmitoylphosphatidylglycerol sodium; Palmitic acid.
  • The patient has any of the following conditions: right-left shunt, severe pulmonary hypertension (pulmonary blood pressure > 90 mm Hg), uncontrolled systemic hypertension and respiratory distress syndrome.
  • Lack of social security coverage, patient under justice
  • Allergy to ultrasound gel
  • Pregnancy. (As a precautionary measure, it is best to avoid using SonoVue during pregnancy according to SPC)
  • Patient under guardianship or curatorship or under the protection of justice.
  • Patient unable or unwilling to give written consent

结局指标

主要结局

Neovascularization of the carotid plaque

时间窗: end of inclusions

Correlation BETWEEN the average signal strength of the carotid plaque analyzed after injection of ultrasound contrast medium by three-dimensional probe with UF-Doppler AND the number of neovessels determined by histological analysis of the carotid plaque (number of neovessels per section) studied.

次要结局

  • Plaque symptomatic or not(end of inclusions)
  • Plaque stable or unstable(end of inclusions)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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