Moyamoya DiseaseSEST-MOYANCT06817434
Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Revascularization/Conservative management
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 31 Dec 2026
- How long will I take part?
- 18 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria.
Who may be able to join
- The imaging examination meets the diagnostic criteria for moyamoya disease;
- Sign the informed consent form;
- Age ≥18 years old;
- Baseline mRS score ≤2 points;
- The patient receives revascularization/conservative treatment;
- There is at least 1 imaging follow-up result.
Who cannot join
- Patients with atherosclerosis, autoimmune diseases, meningitis, Down syndrome, cranial trauma, or those who have undergone radioactive head irradiation, as these conditions may lead to secondary cerebrovascular disease and contribute to the development of Moyamoya syndrome;
- Individuals under the age of 18;
- Participants who refuse to take part in this study;
- Pregnant patients;
- Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;
- A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;
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- Individuals with a history of coronary heart disease or previous cardiovascular and cerebrovascular surgical interventions, including cerebral revascularization, intracranial artery stent implantation, carotid artery stenting, endarterectomy, coronary artery bypass grafting, or coronary stent implantation;
- Allergies to contrast media;
- Patients with missing imaging data or whose image quality cannot be analyzed;
- Individuals who refuse or are unable to undergo imaging follow-up;
- Patients receiving other types of lipid-lowering drug treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, China, 100070
Qian Zhang, MD, 8613120012579, zhangqianchina@yahoo.com
About this study
The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.
- Conditions
- Moyamoya Disease
- Being tested
- Revascularization/Conservative management
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization/Conservative managementDrug
Revascularization/Conservative management
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)
The occurrence of cerebrovascular events, including TIA, ischemic stroke, or hemorrhagic stroke, will be assessed over an 18-month follow-up period.
Measured: 18 months during follow-up
Secondary outcomes (7)
Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment
The mRS and NIHSS will be used to assess changes in neurological function at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment
The MoCA and MMSE will be used to evaluate changes in cognitive function at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Structural Remodeling of the Internal Carotid Artery Terminal and Middle Cerebral Artery Wall at 12 and 18 Months After Treatment
High-resolution magnetic resonance vessel wall imaging will be used to evaluate structural remodeling changes in the internal carotid artery terminal and middle cerebral artery wall at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment
ASL will be used to assess cerebral blood perfusion changes at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment
The occurrence of new cerebral infarcts at 12 and 18 Months after treatment will be evaluated using MRI.
Measured: 12 and 18 months during follow-up
Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment
4D-Flow MRI and hemodynamic analysis will be used to evaluate changes in hemodynamics at the internal carotid artery terminal at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Changes in Blood Lipid Levels at 12 and 18 Months After Treatment
Blood lipid levels will be measured and compared at 12 and 18 months after treatment.
Measured: 12 and 18 months during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start15 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817434
- Sponsor's protocol ID
- KY2023-297-02
- Acronym
- SEST-MOYA
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No