NCT04696094

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

January 4, 2021

Last Update Submit

February 16, 2022

Conditions

Keywords

m6A

Outcome Measures

Primary Outcomes (1)

  • m6A RNA modification in peripheral blood

    m6A RNA modification in peripheral blood

    2021.1.1-2021.12.31

Secondary Outcomes (3)

  • Suzuki grade

    30days

  • Modified Rankin Scale score

    6months

  • New clinical vascular events

    6 months

Study Arms (2)

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.

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Moyamoya disease patients

You may qualify if:

  • Age between 4-60; Male or female;

You may not qualify if:

  • Exclude the volunteers with history of cerebrovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations