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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03613701
Other study ID # 8157113
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 1, 2020

Study information

Verified date January 2019
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Lian Duan, Chief
Phone 0086-10-66947156
Email keyan307@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Moyamoya disease is a chronic cerebrovascular diseaseļ¼ŒThe typical pathological manifestations are the stenosis or occlusion of the distal internal carotid artery and/or middle cerebral artery, and the proximal anterior cerebral artery. Meanwhile, the abnormal vascular net, which is the smokey vessel, occurs at the bottom of the brain. Currently the pathogenesis of this disease is unknown. Limited studies have reported the expression of endothelial progenitor cells (EPCs) in moyamoya disease, but the results were inconsistent. Some investigators believe that the number of EPCs in peripheral blood of patients with moyamoya disease is increased, while others believe that the number of EPCs in peripheral blood of moyamoya patients is reduced. Therefore, the investigators need to find a more accurate detection method to confirm the growth of EPC in patients with moyamoya disease. At the same time, whether there is endothelial injury in patients with smoke disease, and the expression of endothelial cells (CEC) in patients with smoke disease, there is no research on this aspect at home and abroad.


Description:

Objective: Detect the expression of endothelial progenitor cells and endothelial cells from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.

Design: A single center study, and planned to enroll 120 patients. The present study was to detect the quantities of EPC from peripheral blood in Moyamoya disease by flow cytometry, and to identify the relationship of endothelial progeIlitor cells and effect of the revascularization on Moyamoya disease. The present study also use cerebral ischemia animal model foe intervention experiment, to explore whether EPC can promote vascular remodeling effect of ischemic cerebrovascular disease, and to provide new thought for the treatment of chronic cerebrovascular disorder.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 1, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1. Whole-brain vessels angiography or magnetic resonance arteriography (MRA) has the following manifestations: stenosis or occlusion of terminal internal carotid artery or the anterior cerebral artery and/or initiating middle cerebral artery; In the arterial phase, the abnormal smokey vascular net near the occlusive or stenosis lesion can be seen.

2. For patients with stable stroke, there was no acute or subacute cerebral infarction or cerebral hemorrhage, and at least 3 months before the last cerebral infarction or cerebral hemorrhage events.

Exclusion Criteria:

1. Exclude atherosclerosis, autoimmune diseases, meningitis, intracranial tumors, multiple neurofibromatosis, Down syndrome, craniocerebral trauma, radiation injury, and other underlying diseases that may cause smoke.

2. Acute or subacute cerebral infarction or cerebral hemorrhage were excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The 307th Hospital of Military Chinese People's Liberation Army Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expression of endothelial progenitor cells and endothelial cells in peripheral blood Expression of endothelial progenitor cells and endothelial cells in peripheral 2017.9-2018.8
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