A Prospective, Observational Study on Prediction of Risk of Vascular Structural Damage in Patients with Large Vessel Vasculitis(LVV) Based on PET/MRA Image Evaluation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vascular structural progression
研究概览
简要总结
Large vessel vasculitis (LVV) causes vascular inflammation, leading to serious complications such as aneurysm formation and stroke. It is difficult to identify the inflammation of the vessel wall by the current imaging methods, thus affecting the timing of treatment and selection of treatment options. Improved examination methods to determine disease activity are highly needed to guide treatment.
详细描述
This study was designed to assess vascular wall inflammation in patients with large vessel vasculitis by positron emission tomography and magnetic resonance imaging (PET/MRA). The study has a 12-month follow-up period. After completing the baseline clinical assessment, laboratory test and PET/MRA assessment, the intervention protocol will be determined by clinicians. The patients will visit the clinic every 1-2 months according to their specific conditions. Clinical assessment, laboratory test and PET/MRA re-examination will be completed at 6 and 12 months after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically suspected or confirmed LVV and willing to undergo PET/MRA
- •Compliance with long-term follow-up
- •Sign informed consent.
排除标准
- •Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency.
- •Severe mental disorders, severe claustrophobia unable to cooperate with the examination.
- •Patients equipped with cardiac pacemaker, artificial heart valve, ferromagnetic vascular clamp after vascular surgery, aneurysm clamp, artificial cochlea, insulin pump and other drug dosage control devices, steel nail plate and other metal internal fixation, artificial joint, electronic eye, artificial eye.
- •Allergic to contrast medium.
- •Pregnant or lactating women.
- •Withdrawal criteria:
- •Any exclusion criteria emerged during patient follow-up.
- •Voluntarily withdrew from the study.
研究组 & 干预措施
Clinically suspected or confirmed large vessel vasculitis (LVV)
干预措施: glucocorticoid, immunosuppressants, targeted therapy (Drug)
结局指标
主要结局
Vascular structural progression
时间窗: 12 months
Vascular structural progression indicated by PET/MRA (including new vessel wall thickening, increased thickening, vascular stenosis or occlusion, aneurysm formation)
次要结局
- SUV max(12 months)
- TBA(12 months)
研究者
Rui LIU, MD
MD
Nanjing Medical University