Study on Evaluating the Effectiveness of Statins in the Treatment of Moyamoya Disease (SEST-MOYA)

February 4, 2025 updated by: Beijing Tiantan Hospital
The purpose of this study is to investigate the effectiveness of statins in the treatment of moyamoya disease based on multimodal magnetic resonance imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. The imaging examination meets the diagnostic criteria for moyamoya disease;
  2. Sign the informed consent form;
  3. Age ≥18 years old;
  4. Baseline mRS score ≤2 points;
  5. The patient receives revascularization/conservative treatment;
  6. There is at least 1 imaging follow-up result.

Exclusion Criteria:

  1. 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;
  2. Individuals under the age of 18;
  3. Participants who refuse to take part in this study;
  4. Pregnant patients;
  5. Those with concurrent intracranial aneurysms, cerebrovascular malformations, brain tumors, or hydrocephalus;
  6. A history of stroke occurring more than three months prior to the diagnosis of Moyamoya disease;
  7. 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;
  8. Allergies to contrast media;
  9. Patients with missing imaging data or whose image quality cannot be analyzed;
  10. Individuals who refuse or are unable to undergo imaging follow-up;
  11. Patients receiving other types of lipid-lowering drug treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months during follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 and 18 months during follow-up
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.
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
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.
12 and 18 months during follow-up
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.
12 and 18 months during follow-up
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.
12 and 18 months during follow-up
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.
12 and 18 months during follow-up
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.
12 and 18 months during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-297-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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