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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04696094
Other study ID # KY 2020-118-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2022
Source Beijing Tiantan Hospital
Contact Qian Zhang, MD
Phone 008613611075005
Email zhangqianchina@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 60 Years
Eligibility Health volunteers' inclusion criteria: Age between 4-60; Male or female; Exclusion criteria: Exclude the volunteers with history of cerebrovascular disease.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Beijing Tiantan Hospital Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary m6A RNA modification in peripheral blood m6A RNA modification in peripheral blood 2021.1.1-2021.12.31
Secondary 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.
30days
Secondary 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.
6months
Secondary New clinical vascular events New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA) 6 months
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