CClinicalTrials.gg
RecruitingNCT05332756Updated Dec 19, 2024

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

An observational study in Moyamoya Disease, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
2 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Moyamoya Disease

Browse trials for

Keywords

  • Moyamoya Disease
  • Conservative management
  • Long-term follow-up
  • First-degree relatives
03

In context

Moyamoya Disease

60 studies on the registry are indexed under Moyamoya Disease; 25 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 29 observational studies indexed under Moyamoya Disease.

Browse Moyamoya Disease studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Moyamoya disease patients

    Other: Conservative management

  • First-degree relatives of patients with Moyamoya Disease

Interventions

  • OtherConservative management

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

06

What researchers measure

Primary outcomes

  1. Cerebrovascular events

    Time frame: 6 months

  2. Cerebrovascular events

    Time frame: 1 year

  3. Cerebrovascular events

    Time frame: 2 years

  4. Cerebrovascular events

    Time frame: 5 years

Secondary outcomes

  1. Identification of RNF213 variants

    Time frame: Baseline

  2. Unfavorable neurological outcome (mRS>2)

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

  3. Change in cerebral perfusion status as assessed by CTP

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

  4. Change in immunological, inflammatory, angiogenesis biomarkers of peripheral blood

    Serum, plasma, RNA, immune cells and cytokines

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

  5. Change in angiographic features as assessed by CTA

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

  6. Change in angiographic characteristics as assessed by MRA

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

  7. Change in radiological characteristics as assessed by HR-MRI

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

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital Capital Medical University
    Beijing, Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05332756
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Sponsor
First posted
Apr 18, 2022
Start date
May 1, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 19, 2024

Study contacts

Qian Zhang, MD
Contact
zhangqianchina@yahoo.com
8613120012579
Chaofan Zeng, MD
Contact
zchf723@163.com
8613693276138

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion