Moyamoya DiseaseNCT04696094
The Role of m6A RNA Modification in Moyamoya Disease
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 detect the change of m6A RNA modification from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics. Read more about this study
- Who is it for?
- Ages 4 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Moyamoya disease patients
Who may be able to join
None listed.
Who cannot join
- Exclude the volunteers with history of cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality
About this study
The purpose of this study is to detect the change of m6A RNA modification from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.
Read the detailed description
Moyamoya disease (MMD) is a rare cerebrovascular disorder characterized by occlusion of bilateral internal carotid and intracerebral arteries with the compensatory growth of fragile small vessels. The etiology of disease is still unclear. The pathology is associated with blood vessels, characterizing the molecular changes of blood in patients with MMD may yield insights into the disease. N6-methyladenosine (m6A) is identified to be the most common and abundant RNA molecular modification in eukaryotes, and involves in a variety of metabolic processes of RNA, such as RNA transcription, shearing, nuclear transport, and translation ability. The propose of this study is to investigate the change of m6A RNA modification in patients blood with moyamoya disease and its influence on clinical indicators, aiming to provide potential pathogenesis of moyamoya disease.
- Conditions
- Moyamoya Disease
- Keywords
- m6A
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Health volunteers' inclusion criteria: Age between 4-60; Male or female; Exclusion criteria: Exclude the volunteers with history of cerebrovascular disease. | |
| Moyamoya disease patients | Moyamoya disease patients' inclusion Criteria: 1.written informed consent had been obtained; 2. more than 4 years old and less than 60 years old; 3. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate 'moyamoya collaterals'; 4. received surgical revascularization; Exclusion Criteria: 1. There are other vascular 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. Physical or subjective failure to cooperate with the examination or serious comorbid diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
m6A RNA modification in peripheral blood
m6A RNA modification in peripheral blood
Measured: 2021.1.1-2021.12.31
Secondary outcomes (3)
Suzuki grade
Stage 1 stenosis of the carotid artery at its suprasellar portion, usually bilateral; Stage 2 moyamoya vessels begin to develop at the base of the brain; Stage 3 moyamoya vessels become more prominent as major trunks in the anterior circulation become severely stenotic or occluded; Stage 4 posterior cerebral arteries are occluded, moyamoya vessels begin to diminish and collateral pathways from extracranial circulation develop; Stage 5, moyamoya vessels are diminishing and extracranial circulation progresses; Stage 6, moyamoya vessels and the major cerebral arteries completely disappear, the cerebral hemispheres receive blood through the abnormal extracranial-intracranial anastomosis.
Higher scores mean a worse outcome.
Measured: 30days
Modified Rankin Scale score
0 No symptoms at all; 1 No significant disability despite symptoms, able to carry out all usual duties and activities; 2 Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance; 3 Moderate disability, requiring some help, but able to walk without assistance; 4 Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 Severe disability, bedridden, incontinent and requiring constant nursing care and attention.
Higher scores mean a worse outcome.
Measured: 6months
New clinical vascular events
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 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
- NCT04696094
- Sponsor's protocol ID
- KY 2020-118-03
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2021
- Last updated
- 17 Feb 2022
- Results posted
- 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 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of m6A RNA Modification in Moyamoya Disease
- ClinicalTrials.gov ID
- NCT04696094
- Acronym / sponsor ID
- KY 2020-118-03
- Conditions
- Moyamoya Disease
- Keywords
- m6A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jan 2021 (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 detect the change of m6A RNA modification from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.
Detailed description
Moyamoya disease (MMD) is a rare cerebrovascular disorder characterized by occlusion of bilateral internal carotid and intracerebral arteries with the compensatory growth of fragile small vessels. The etiology of disease is still unclear. The pathology is associated with blood vessels, characterizing the molecular changes of blood in patients with MMD may yield insights into the disease. N6-methyladenosine (m6A) is identified to be the most common and abundant RNA molecular modification in eukaryotes, and involves in a variety of metabolic processes of RNA, such as RNA transcription, shearing, nuclear transport, and translation ability. The propose of this study is to investigate the change of m6A RNA modification in patients blood with moyamoya disease and its influence on clinical indicators, aiming to provide potential pathogenesis of moyamoya disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Health volunteers' inclusion criteria: Age between 4-60; Male or female; Exclusion criteria: Exclude the volunteers with history of cerebrovascular disease. |
| Moyamoya disease patients | – | –Moyamoya disease patients' inclusion Criteria: 1.written informed consent had been obtained; 2. more than 4 years old and less than 60 years old; 3. cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate 'moyamoya collaterals'; 4. received surgical revascularization; Exclusion Criteria: 1. There are other vascular 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. Physical or subjective failure to cooperate with the examination or serious comorbid diseases. |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Moyamoya disease patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Exclude the volunteers with history of cerebrovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
m6A RNA modification in peripheral blood
Time frame: 2021.1.1-2021.12.31
m6A RNA modification in peripheral blood
3 secondary outcomes
Suzuki grade
Time frame: 30days
Modified Rankin Scale score
Time frame: 6months
New clinical vascular events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- 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. This study is not recruiting at the moment.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Zhang, MD (008613611075005, zhangqianchina@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
m6A RNA modification in peripheral blood (time frame: 2021.1.1-2021.12.31). 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 17 Feb 2022.