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Dimethyl fumarate treatment for unruptured intracranial aneurysms: a study protocol for a double-blind randomised controlled trial

Huang, Jiliang ; Zhang, Yisen ; Turhon, Mirzat ; Zheng, Zhaoxu ; Li, Wenqiang ; Kang, Huibin ; Wang, Chao ; Liu, Jian ; Jiang, Peng

BMJ open, 2024-05, Vol.14 (5), p.e080333-e080333 [Periódico revisado por pares]

England: British Medical Journal Publishing Group

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Título:
Dimethyl fumarate treatment for unruptured intracranial aneurysms: a study protocol for a double-blind randomised controlled trial
Autor: Huang, Jiliang ; Zhang, Yisen ; Turhon, Mirzat ; Zheng, Zhaoxu ; Li, Wenqiang ; Kang, Huibin ; Wang, Chao ; Liu, Jian ; Jiang, Peng
Assuntos: Adult ; Aneurysms ; Anti-Inflammatory Agents - therapeutic use ; Biomarkers ; clinical trial ; Clinical trials ; Dimethyl Fumarate - therapeutic use ; Disease ; Double-Blind Method ; Drug dosages ; Female ; Hospitals ; Humans ; Hypotheses ; immunology ; Inflammation ; Intracranial Aneurysm - drug therapy ; magnetic resonance imaging ; Male ; Medical imaging ; Middle Aged ; Morphology ; Multiple sclerosis ; Neurology ; Oxidative stress ; Randomized Controlled Trials as Topic ; Smooth muscle ; Tumor necrosis factor-TNF ; vascular medicine
É parte de: BMJ open, 2024-05, Vol.14 (5), p.e080333-e080333
Notas: Protocol
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JH and YZ are joint first authors.
Descrição: IntroductionIntracranial aneurysm (IA) is a common cerebrovascular disease. Considering the risks and benefits of surgery, a significant proportion of patients with unruptured IA (UIA) choose conservative observation. Previous studies suggest that inflammation of aneurysm wall is a high-risk factor of rupture. Dimethyl fumarate (DMF) acts as an anti-inflammatory agent by activating nuclear factor erythroid 2-related factor 2 (Nrf2) and other pathways. Animal experiments found DMF reduces the formation and rupture of IAs. In this study, DMF will be evaluated for its ability to reduce inflammation of the aneurysm wall in high-resolution vessel wall imaging.Methods and analysisThis is a multi-centre, randomised, controlled, double-blind clinical trial. Three hospitals will enrol a total of 60 patients who have UIA with enhanced wall. Participants will be assigned randomly in a 1:1 proportion, taking either 240 mg DMF or placebo orally every day for 6 months. As the main result, aneurysm wall enhancement will be measured by the signal intensity after 6 months of DMF treatment. Secondary endpoints include morphological changes of aneurysms and factors associated with inflammation. This study will provide prospective data on the reduction of UIA wall inflammation by DMF.Ethics and disseminationThis study has been approved by Medical Ethics Committee of the Beijing Tiantan Hospital, Capital Medical University (approval no: KY2022-064-02). We plan to disseminate our research findings through peer-reviewed journal publication and relevant academic conferences.Trial registration numberNCT05959759.
Editor: England: British Medical Journal Publishing Group
Idioma: Inglês

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Dimethyl fumarate treatment for unruptured intracranial aneurysms: a study protocol for a double-blind randomised controlled trial

Huang, Jiliang ; Zhang, Yisen ; Turhon, Mirzat ; Zheng, Zhaoxu ; Li, Wenqiang ; Kang, Huibin ; Wang, Chao ; Liu, Jian ; Jiang, Peng

England: British Medical Journal Publishing Group

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