跳至主要内容
临床试验/NCT05856175
NCT05856175招募中不适用

The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
the influence of peri-sinus bony wall morphology on the recurrence of pulsatile tinnitus using CT

研究概览

简要总结

Venous tinnitus (VT) is seriously affecting the quality of life of five million patients in China. Bony wall reconstruction is the main treatment method, but the postoperative recurrence rate exceeds 30%, and the specific mechanism is unclear. Based on our previous work, a scientific hypothesis was put forward: the key to the recurrence of V T is pathologic remodeling of the peri-sinus bony wall mediated by the venous sinus morphology, blood flow, and pressure after surgical reconstruction. As a continuation of the National Natural Science Foundation of China-Youth Project, this project intends to combine multimodal imaging technology, multiphysics coupled numerical model and machine learning method to analyze analyze the data after bone wall reconstruction in multiple dimensions: ① To explore the influence of peri-sinus bony wall morphology, venous sinus morphology, intra-sinus blood flow, intra-sinus pressure, and cerebral perfusion on the recurrence of VT using ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology; ② To explore the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of VT using multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields; ③ To determine the risk factors and their weights of VT recurrence using machine learning methods, and to establish a personalized surgical planning and prognostic evaluation models; Thus, to verify the hemodynamic and biomechanical mechanisms of VPT recurrence to achieve personalized and effectively treatment. This project may prevent and warn the recurrence of VPT after bony wall reconstruction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with venous tinnitus, a rhythmic noise that follows the heart beating without external stimuli and can disappear or significantly reduce after compression of the affected side of the neck
  • the normal otoscopy
  • venous tinnitus patients with confirmed sigmoid sinus wall dehiscence with or without sigmoid sinuses enlargement, diverticula and transverse sinuses stenosis using dual-phase enhanced CT examination
  • preoperative DSA examination
  • bone wall reconstruction

排除标准

  • contraindications for CT and MR Examination
  • tumor and arterial abnormalities

结局指标

主要结局

the influence of peri-sinus bony wall morphology on the recurrence of pulsatile tinnitus using CT

时间窗: 2023.6.1-2025.12.31

ultra-high resolution CT

the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of pulsatile tinnitus

时间窗: 2023.6.1-2025.12.31

multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields

the risk factors and their weights of pulsatile tinnitus recurrence

时间窗: 2023.6.1-2025.12.31

Ensight, a post-processing software, was used to study the interaction between hemodynamic features and acoustic features with multivariate analysis and machine learning methods.

the influence of cerebral perfusion on the recurrence of pulsatile tinnitus using MRI

时间窗: 2023.6.1-2025.12.31

ASL MR imaging technology

the influence of venous sinus morphology, intra-sinus blood flow, and intra-sinus pressure on the recurrence of pulsatile tinnitus using MRI

时间窗: 2023.6.1-2025.12.31

4D Flow MR imaging technology

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang, Zhenchang

Vice President, Director of Medical Imaging Center

Beijing Friendship Hospital

研究点 (1)

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