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Long-term Outcomes of Conservative Management in Patients with Moyamoya Disease and Their First-degree Relatives (LAMORA)

NCT ID: NCT05332756

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to investigate the long-term outcomes of conservative management in patients with moyamoya disease and their first-degree relatives, and provide potential pathogenesis of moyamoya disease.

Detailed Description

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Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. However, the long-term outcomes of MMD with conservative management remain unknown. Also, some first-degree relatives who are carriers of genetic variants occasionally manifest with intracranial arterial stenosis. Therefore, it is significant to detect the long-term outcomes of conservative treatment in MMD patients and their first-degree relatives, and thus provide potential pathogenesis of MMD.

Conditions

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Moyamoya Disease

Keywords

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Moyamoya Disease Conservative management Long-term follow-up First-degree relatives

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moyamoya disease patients

Conservative management

Intervention Type OTHER

Patients and their first-degree relatives will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.

First-degree relatives of patients with Moyamoya Disease

No interventions assigned to this group

Interventions

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Conservative management

Patients and their first-degree relatives will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with age between 2-60 years;
2. A clinical diagnosis of moyamoya disease, including unilateral and bilateral disease.
3. Patients are medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
4. Capable of understanding the purpose and risk of the study and has signed the informed consent. If the participant is not capable of this at the time of enrollment, a legally authorized representative will provide written informed consent in accordance with all regulations.
5. Ability to comply with study follow-up.

Exclusion Criteria

1. Concomitant other diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy.
2. Patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement.
3. Patients are allergic to the contrast agents.
4. Patients are treated with direct, indirect, or combined revascularization depending on the presentation.
5. Physical or subjective failure to cooperate with the examination or serious comorbid diseases.
6. Patients are unable or unlikely to return for follow-up visits.
7. Any other reasons that, in the opinion of the investigators, make the participant unsuitable for enrollment.
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Zhang, MD

Role: CONTACT

Phone: 8613120012579

Email: [email protected]

Chaofan Zeng, MD

Role: CONTACT

Phone: 8613693276138

Email: [email protected]

Other Identifiers

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KY2021-186-02

Identifier Type: -

Identifier Source: org_study_id