The Role of m6A RNA Modification in Moyamoya Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Moyamoya Disease

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Qian Zhang, MD; Phone Number: 008613611075005; Email: zhangqianchina@yahoo.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tiantan Hospital Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Moyamoya disease patients

Description

Health volunteers' inclusion criteria:

Age between 4-60; Male or female;

Exclusion criteria:

Exclude the volunteers with history of cerebrovascular disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
m6A RNA modification in peripheral blood	m6A RNA modification in peripheral blood	2021.1.1-2021.12.31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
New clinical vascular events	New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA)	6 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: m6A
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Moyamoya Disease
• Other Study ID Numbers: KY 2020-118-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No