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

NCT06817434 | Recruiting

• 1 other identifier: KY2023-297-02
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months during follow-up

Secondary Outcomes (7)

• Changes in Neurological Function (mRS, NIHSS) 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

  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

  12 and 18 months during follow-up

• Changes in Cerebral Blood Perfusion 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

  12 and 18 months during follow-up

Interventions

Revascularization/Conservative management DRUG

Revascularization/Conservative management

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China, 100070, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Qian Zhang

CONTACT

8613120012579; zhangqianchina@yahoo.com

Chaofan Zeng

CONTACT

8613693276138; zchf723@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 10, 2025
• Study Start: December 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)