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Идёт набор NCT05332756

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

— Наблюдательное Moyamoya Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Conservative management.
Кому может быть актуально
Состояния в реестре: Moyamoya Disease. Базовые параметры: 2 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital Capital Medical University — Пекин

Идентификаторы

NCT: NCT05332756 · KY2021-186-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗