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Recruiting NCT05332756

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

— Observational Moyamoya Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conservative management.
Who it may be relevant to
Registry conditions: Moyamoya Disease. Basic parameters: 2 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Cerebrovascular events [Time frame: 6 months]
  • Cerebrovascular events [Time frame: 1 year]
  • Cerebrovascular events [Time frame: 2 years]
  • Cerebrovascular events [Time frame: 5 years]
Secondary outcome measures (7)
  • Identification of RNF213 variants [Time frame: Baseline]
  • Unfavorable neurological outcome (mRS>2) [Time frame: 6 months, 1 year, 2 years, and 5 years during follow-up]
  • Change in cerebral perfusion status as assessed by CTP [Time frame: Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up]
  • Change in immunological, inflammatory, angiogenesis biomarkers of peripheral blood [Time frame: Baseline, 1 year, 2 years, and 5 years during follow-up]
  • Change in angiographic features as assessed by CTA [Time frame: Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up]
  • Change in angiographic characteristics as assessed by MRA [Time frame: Baseline, 1 year, 2 years, and 5 years during follow-up]
  • Change in radiological characteristics as assessed by HR-MRI [Time frame: Baseline, 1 year, 2 years, and 5 years during follow-up]

Eligibility criteria

Inclusion criteria

  • Patients with age between 2-60 years;
  • A clinical diagnosis of moyamoya disease, including unilateral and bilateral disease.
  • Patients are medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
  • 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.
  • Ability to comply with study follow-up.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital Capital Medical University — Beijing

Identifiers

NCT: NCT05332756 · KY2021-186-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗