NCT07634068尚未招募2 期
Vertebrobasilar Dolichoectasia Treatment With Amiloride: a Pilot Study Based On 5.0 T MRI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
研究概览
简要总结
The aim of this pilot study is to assess the efficacy of amiloride in reducing wall enhancement in vertebrobasilar dolichoectasia(VBD) on high-resolution magnetic resonance vessel wall imaging(HR-VWI) via anti-inflammatory mechanisms, clarify the efficacy of amiloride in delaying the progression of VBD, evaluate the safety of amiloride in the treatment of VBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Age≥18 years, any gender;
- •Patients with VBD confirmed by DSA/CTA/MRA;
- •No history of VBD rupture and no surgical treatment for VBD;
- •Positive plasma SGK1;
- •No history of posterior circulation stroke, and no symptoms or signs related to VBD;
- •No need for subsequent use of antiplatelet or statin drugs;
- •Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
排除标准
- •History of malignant tumors, systemic lupus erythematosus, or gout;
- •Pregnancy or lactation;
- •Amiloride or sulfonamide allergy;
- •Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment;
- •Abnormal hepatic and/or renal function (serum transaminase > 40 U/L; serum creatinine > 110 μmol/L); and/or abnormal white blood cells/platelets (white blood cells count < 3.5 × 10⁹/L or > 9.5 × 10⁹/L; platelets count < 100 × 10⁹/L or > 300 × 10⁹/L); hyperkalemia, hypokalemia, hyponatremia, or hypercalcemia;
- •Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction;
- •Acute stage of intracranial hemorrhage as indicated by CT;
- •History of VBD rupture or surgery;
- •Presence of acute active infection (such as severe bacterial, viral or fungal infection);
- •Uncontrolled diabetes (HbA1c≥7%);
- •Need for subsequent use of antiplatelet or statin drugs;
- •Systolic blood pressure< 90 mmHg or/and diastolic blood pressure< 60 mmHg;
- •Currently participating in other clinical studies;
- •Presence of contraindications for MRI examination;
- •Other situations not suitable for inclusion.
研究者
Wei Zhu
Principal Investigator
Huashan Hospital
研究点 (1)
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