Beijing Neurosurgical Institute & Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT05959759
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100070, China
Intracranial aneurysm (IA) is a common cerebrovascular disease and the main cause of nontraumatic subarachnoid hemorrhage. Once ruptured, it will cause a high mortality rate, and nearly half of the survivors will also have disabilities. After comparing surgical risk and rupture risk, a significant proportion of patients with intracranial aneurysms choose conservative observation.
Previous studies suggest that inflammation of aneurysmal 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 dimethyl fumarate reduces the formation and rupture of intracranial aneurysms.
MRI High-resolution vessel wall imaging (HR-VWI) has become a valuable method to assess the Wall of unruptured intracranial aneurysms. Using HR-VWI, it may be possible to detect smaller or more subtle areas of signal enhancement and change, which may give a more precise understanding of the pathology.
In this study, DMF was evaluated for its ability to reduce inflammation of the aneurysm wall measured with High-resolution Vessel Wall Imaging (HR-VWI).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dimethyl fumarate enteric capsule (the initial dose is 120 mg twice a day, and after 7 days, the dose will be increased to the maintenance dose of 240 mg twice a day, for 6 months), 30 patients for this arm.
placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.
Time frame: 6 months
At the end of 6 months, the changes of Wall enhancement index (WEI) and wall enhancement volume rate (WEVR) on HR-VW-MRI will be quantitatively compared between the DMF group and placebo group.
Time frame: 6 months
The proportion of morphological growth of aneurysms from before treatment to the 6 months follow-up. An increase ≥ 1mm in any diameter or the appearance of a daughter sac will be defined as growth in aneurysmal morphology.
Time frame: 6 months
Changes in CRP, TNF-α, IL-Iβ, IL-2R, IL-6, IL-8 and IL-10 in patients with unruptured IAs from before treatment to the 6 months follow-up. The inflammatory markers levels will be measured at before treatment and at 6 months follow-up.
Beijing Tiantan Hospital
Other
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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