Evidence map›Paper›PMID 38772883›Full record

ArticleBMJ open2024

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

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

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05959759 (Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05959759 phase4completednot on this map

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail

TypeinterventionalSponsorBeijing Tiantan HospitalRan2023 to 2026Enrolled60ConditionsIntracranial Aneurysm, Aneurysm, Brain, Inflammation VascularArmsDimethyl fumarate, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jiliang Huang *Neurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0009-0007-3431-0292
Yisen Zhang *Neurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Mirzat TurhonNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4183-6026
Zhaoxu ZhengNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Wenqiang LiNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Huibin KangSouthern Medical University Nanfang Hospital, Guangzhou, China.
Chao WangNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-9954-5881
Jian LiuNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Peng JiangNeurosurgery Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China jiangpeng33@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: NCT05959759.

Indexed as

Dimethyl FumarateIntracranial AneurysmAdultAnti-Inflammatory AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicAnti-Inflammatory AgentsDimethyl Fumarateclinical trialimmunologymagnetic resonance imagingvascular medicine

Identifiers

PMID38772883
PMCPMC11110581

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.