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NCT Number: NCT06817434

Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease

The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Revascularization/Conservative management

Drug

Revascularization/Conservative management

Primary outcomes

  1. Rate of participants experiencing cerebrovascular events (TIA, ischemic stroke, or hemorrhagic stroke)

    Time frame: 18 months during follow-up

    The occurrence of cerebrovascular events, including TIA, ischemic stroke, or hemorrhagic stroke, will be assessed over an 18-month follow-up period.

Secondary outcomes

  1. Changes in Neurological Function (mRS, NIHSS) at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    The mRS and NIHSS will be used to assess changes in neurological function at 12 and 18 months after treatment.

  2. Changes in Cognitive Function (MoCA, MMSE) at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    The MoCA and MMSE will be used to evaluate changes in cognitive function at 12 and 18 months after treatment.

  3. Structural Remodeling of the Internal Carotid Artery Terminal and Middle Cerebral Artery Wall at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    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.

  4. Changes in Cerebral Blood Perfusion at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    ASL will be used to assess cerebral blood perfusion changes at 12 and 18 months after treatment.

  5. Rate of New Cerebral Infarcts at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    The occurrence of new cerebral infarcts at 12 and 18 Months after treatment will be evaluated using MRI.

  6. Hemodynamic Changes at the Internal Carotid Artery Terminal at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    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.

  7. Changes in Blood Lipid Levels at 12 and 18 Months After Treatment

    Time frame: 12 and 18 months during follow-up

    Blood lipid levels will be measured and compared at 12 and 18 months after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Chaofan Zeng

CONTACT

[email protected]

8613693276138

Qian Zhang

CONTACT

[email protected]

8613120012579

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Acronym: SEST-MOYA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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