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临床试验/NCT03785171
NCT03785171Unknown不适用

Multimodal Magnetic Resonance Imaging Predicting Outcome After Surgical Revascularization in Patients With Moyamoya Disease

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Patients selection/stratification

研究概览

简要总结

Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and their proximal branches, with subsequent formation of collateral vessels ("puff of smoke"). In some cases, the posterior circulation can also be involved. MMD has been discovered around the world, but Asians carry the most possibility to develop this disease. Current treatment designed to prevent strokes by improving blood flow to the affected cerebral hemisphere including medical therapy and surgery. In particular, surgery included two general methods: direct and indirect revascularization. Compared with direct bypass, indirect procedures are more technically accessible and may reduce the possibility of complications, such as hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have shown great potential in evaluating perfusion in patients, and could possibly predict surgical outcome. However, there is still lack of evidence of the predictive value of MRI in evaluating clinical and angiography improvement in patients with MMD.

详细描述

Imaging protocols:

3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST

Imaging evaluation:

  1. Transfer contrast volume value measured by DCE;
  2. ASL shows CBF in associated regions;
  3. Stoke area measured by DWI and Flair;
  4. PH values reflected by APT-CEST.

Treatment:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery;
  • Abnormal vascular network appeared in the brain;
  • With the onset of cerebral ischemia/hemorrhage/TIA;
  • No cerebral infarction or cerebral hemorrhage occurred within the last month;
  • All MRI examination performed according to study protocol;
  • Signed informed consent obtained from the patient or patient's legally authorized representative;
  • Having complete medical history and clinical follow up;
  • Imaging data can be processed.

排除标准

  • Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc.;
  • Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.
  • Pregnancy

结局指标

主要结局

Patients selection/stratification

时间窗: Three months to 6 months

Finding the effect of imaging biomarkers/patterns to provide therapy decision support

次要结局

  • Surgical outcome(Three months to 6 months)
  • Surgical response(Three months to 6 months)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Lou

Deputy Director of Department of Radiology

Chinese PLA General Hospital

研究点 (1)

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