Moyamoya DiseaseNCT05332756
Long-term Outcomes of Conservative Management in Patients with Moyamoya Disease and Their First-degree Relatives (LAMORA)
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Conservative management
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: Long-term Outcomes of Conservative Management in Patients with Moyamoya Disease and Their First-degree Relatives
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.
- Conditions
- Moyamoya Disease
- Being tested
- Conservative management
- Keywords
- Moyamoya Disease, Conservative management, Long-term follow-up, First-degree relatives
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative managementOther
Patients and their first-degree relatives will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
| Study group | Role | What they receive |
|---|---|---|
| Moyamoya disease patients | Not described Receives: Other: Conservative management | |
| First-degree relatives of patients with Moyamoya Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular events
Measured: 6 months
Cerebrovascular events
Measured: 1 year
Cerebrovascular events
Measured: 2 years
Cerebrovascular events
Measured: 5 years
Secondary outcomes (7)
Identification of RNF213 variants
Measured: Baseline
Unfavorable neurological outcome (mRS>2)
Measured: 6 months, 1 year, 2 years, and 5 years during follow-up
Change in cerebral perfusion status as assessed by CTP
Measured: Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up
Change in immunological, inflammatory, angiogenesis biomarkers of peripheral blood
Serum, plasma, RNA, immune cells and cytokines
Measured: Baseline, 1 year, 2 years, and 5 years during follow-up
Change in angiographic features as assessed by CTA
Measured: Baseline, 6 months, 1 year, 2 years, and 5 years during follow-up
Change in angiographic characteristics as assessed by MRA
Measured: Baseline, 1 year, 2 years, and 5 years during follow-up
Change in radiological characteristics as assessed by HR-MRI
Measured: Baseline, 1 year, 2 years, and 5 years during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 May 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332756
- Sponsor's protocol ID
- KY2021-186-02
- Status last verified
- Dec 2024
- First submitted
- 31 Mar 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Conservative Management in Patients with Moyamoya Disease and Their First-degree Relatives
- ClinicalTrials.gov ID
- NCT05332756
- Acronym / sponsor ID
- KY2021-186-02
- Conditions
- Moyamoya Disease
- Keywords
- Moyamoya Disease, Conservative management, Long-term follow-up, First-degree relatives
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moyamoya disease patients | – | Other: Conservative management |
| First-degree relatives of patients with Moyamoya Disease | – | – |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative managementPatients and their first-degree relatives will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation. | Other | Moyamoya disease patients |
Primary outcome
Cerebrovascular events
Time frame: 6 months
Cerebrovascular events
Time frame: 1 year
Cerebrovascular events
Time frame: 2 years
Cerebrovascular events
Time frame: 5 years
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Zhang, MD (8613120012579, zhangqianchina@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular events (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.