The Safety and Efficacy of RIC on Adult Moyamoya Disease

Moyamoya Disease Clinical Trial

— RIC-AMD  

Official title:

The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012268
• Other study ID #: RIC-AMD
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2021
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.

Description:

There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.

Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2, 2021
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age: 18-60 years

• All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.

• mRs=3

• Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

• Patients with acute ischemic or hemorrhagic stroke within 3 months.

• Severe hepatic or renal dysfunction.

• Severe hemostatic disorder or severe coagulation dysfunction.

• Severe cardiac diseases.

• Patients with severe existing neurological or psychiatric disease

• Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.

• Patients have been done or plan to accept revascularization surgery.

Related Conditions & MeSH terms

• Moyamoya Disease

Intervention

Device:
• RIC
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.

Drug:
• Aspirin
patients will accept medication guided by neurologists

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement ratio of mean cerebral blood flow	Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.	change from the baseline to12 months after treatment
Secondary	incidence of ischemic stroke	ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.	from the baseline to 12 months after treatment
Secondary	incidence of transient ischemic attack	TIA is diagnosed by patients' transient neurologic deficit	from the baseline to 12 months after treatment
Secondary	incidence of hemorrhagic stroke	hemorrhagic stroke is diagnosed by head CT	from the baseline to 12 months after treatment
Secondary	The level of matrix metalloproteinase 9 (MMP-9)	Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation	change from the baseline to 3, 6, 12 months after treatment
Secondary	The level of vascular endothelial growth factor	Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation	change from the baseline to 3, 6, 12 months after treatment
Secondary	The level of basic fibroblast growth factor	Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation	change from the baseline to 3, 6 ,12 months after treatment
Secondary	The rate of death and adverse event	All causes of death will be included to compute mortality at 12 months after therapy	change from the baseline to 12 months after treatment
Secondary	The number of patients with erythema,and/or skin lesions related to RIC	Professional doctors will check it and the investigator will record the number.	change from the baseline to 12 months after treatment
Secondary	The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure	the investigator will record the number.	change from the baseline to 12 months after treatment
Secondary	The rate of progression of stenosis or occlusion at Willis circle	Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.	12 months after therapy