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

ConditionMoyamoya Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-60
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Conservative management

    Other intervention

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Moyamoya disease patients1 intervention
Group B: First-degree relatives of patients with Moyamoya Disease0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov
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