2023-504547-14-01招募中4 期
Calcium Channel blocker in treatment of reversible cerebral vasoconstriction syndrome: a double-blind, randomized, placebo-controlled trial.
HUS Helsinki University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月5日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of recurring headache
研究概览
简要总结
The main objective of the study is to test the hypothesis that the addition of a calcium channel blocker on top of standard care can reduce the frequency of recurrent headache attacks in patients diagnosed with reversible cerebral vasoconstriction syndrome without parenchymal lesions or subarachnoid hemorrhage on CT/MRI.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at entry
- •Thunderclap headache (reaching peak intensity within ≤1 minute) or severe recurrent headache
- •Cerebral vasoconstriction on imaging in at least 2 different arteries or cerebral vasoconstriction in one artery and typical clinical picture with thunderclap headache
- •Absence of acute or subacute infarction, hemorrhage or findings suggesting posterior reversible encephalopathy syndrome on CT/MRI.
- •Absence of aneurysmal subarachnoid hemorrhage (SAH)
排除标准
- •Ongoing usage of calcium channel blockers before the index event
- •Parenchymal lesions on CT/MRI (ischemic lesions, intracerebral hemorrhage, posterior reversible encephalopathy syndrome)
- •Subarachnoid hemorrhage on CT/MRI
- •Clinical suspicion of PACNS or other CNS vasculitis
- •An abnormal cerebrospinal fluid (CSF) finding, if a lumbar puncture is performed.
结局指标
主要结局
Frequency of recurring headache
Frequency of recurring headache
次要结局
- Occurrence of any radiological complication (ischemic stroke, SAH, ICH, PRES) on computed tomography or magnetic resonance tomography
- Radiological reversibility of the vasoconstriction on the follow-up CTA/MRA
- Intensity of recurring headache attacks
研究者
Sami Curtze
Scientific
HUS Helsinki University Hospital
研究点 (1)
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