Clinical trial NCT05959759: Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
Official title: Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Intracranial Aneurysm
Aneurysm, Brain
Inflammation Vascular
Keywords: Dimethyl Fumarate
High resolution magnetic resonance
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Neurosurgical Institute
name: Beijing Chao Yang Hospital
name: Henan Provincial People's Hospital
First posted: 2023-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 60 patients will be enrolled in this study. Randomly divide the patients into experimental group and placebo group according to 1:1 ratio.
Primary purpose: TREATMENT

Brief summary: This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥18 years.
2. Unruptured IA of ≥3mm identified on imaging (CT, MRI or digital subtraction angiography).
3. Aneurysm wall enhancement identified by HR-VWI before treatment.
4. Ability to understand the objective of the trial with provision of written informed consent.

Exclusion Criteria:

1. MRI contraindications (metallic implant, contrast allergy, claustrophobia, etc).
2. Planned treatment of the aneurysm within 12 months.
3. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, etc.).
4. Severely impaired liver or renal function.
5. Retreatment of recurrent aneurysm.
6. Pregnant or lactating women.
7. Malignant diseases (liver disease, kidney disease, congestive heart failure, malignant tumours, etc.).
8. Poor compliance.

Primary outcomes:
measure: Change of aneurysm wall inflammation as measured by HR-VW-MRI.
timeFrame: 6 months
Secondary outcomes:
measure: Change of aneurysmal morphology parameter
timeFrame: 6 months
measure: Change of inflammatory markers in patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute & Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Neurosurgical Institute & Beijing Tiantan Hospital
name: Yisen Zhang, MD
role: STUDY_DIRECTOR
References: