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

NCT05332756 | Recruiting

• 1 other identifier: KY2021-186-02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moyamoya Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Cerebrovascular events

  6 months

• Cerebrovascular events

  1 year

• Cerebrovascular events

  2 years

• Cerebrovascular events

  5 years

Secondary Outcomes (7)

• Identification of RNF213 variants

  Baseline

• Unfavorable neurological outcome (mRS>2)

  6 months, 1 year, 2 years, and 5 years during follow-up

• Change in cerebral perfusion status as assessed by CTP

  Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up

• Change in immunological, inflammatory, angiogenesis biomarkers of peripheral blood

  Baseline, 1 year, 2 years, and 5 years during follow-up

• Change in angiographic features as assessed by CTA

  Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up

Study Arms (2)

Moyamoya disease patients

Other: Conservative management

First-degree relatives of patients with Moyamoya Disease

Interventions

Conservative management OTHER

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

Moyamoya disease patients

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria. Relatives will be recruited from the first-degree relatives of patients with MMD.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 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, MD

CONTACT

8613120012579; zhangqianchina@yahoo.com

Chaofan Zeng, MD

CONTACT

8613693276138; zchf723@163.com

Study Design

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

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)