Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease

Moyamoya Disease Clinical Trial

— RIC-IMD  

Official title:

Safety and Efficacy of Remote Ischemic Conditioning Combined Encephaloduroarteriosynangiosis（EDAS）on Ischemic Moyamoya Disease: A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917003
• Other study ID #: RIC-IMD
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2021
• Source: Capital Medical University
• Contact: Xunming Ji, PhD
• Phone: 861013120136877
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Description:

Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.

Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012.

2. Suzuki stage: 2-5 stage

3. Age: between 18 and 65 years old

4. Subjects present with ischemic stroke or transient ischemic attack.

5. Subjects who plan to accept the first EDAS surgery.

6. Informed consent obtained from patient or patient's surrogate

Exclusion Criteria:

1. Acute ischemic stroke occurred within one month.

2. Suffered Intracranial hemorrhage before

3. Subjects with large infarction spread widely over the territory of a main arterial trunk

4. Aneurysms in the main arterial trunk

5. Severe cardiac diseases like atrial fibrillation,valvular disease,heart failure, infective endocarditis and so on.

6. Malignant tumors or severe disordered function of the heart, lung, liver or kidney.

7. Severe hemostatic disorder or severe coagulation dysfunction.

8. Uncontrolled diabetes mellitus with a serum fasting blood glucose level>300 mg/dL, or requires insulin; hypertension with a systolic blood pressure over 180 mmHg or a diastolic blood pressure over 110 mmHg.

9. Severe injury on upper limbs.

10. Pregnant or lactating women.

11. Life expectancy is less than 3 years.

12. Patients who are not suitable for this trial considered by researchers for other reasons

Related Conditions & MeSH terms

• Ischemia
• Moyamoya Disease

Intervention

Other:
• RIC plus EDAS
Patients who are allocated into RIC group will undergo EDAS surgery combined 3-month RIC treatment. The opposite operation will be performed at 3 months after the first operation.
• EDAS
Patients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rCBF changed ratio at operative side	Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination,and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the operative side). The higher value of rCBF improvement ratio means better imaging outcome.	From baseline to 3 months.
Secondary	the change of TTP delay at operative side	Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at operative side will be calculated by the formula: the change of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the operative side). The higher value means better imaging outcome.	From baseline to 3 months.
Secondary	rCBF changed ratio at non-operative side	Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination,and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the non-operative side). The higher value of rCBF improvement ratio means better imaging outcome.	From baseline to 3 months.
Secondary	the change of TTP delay at non-operative side	Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at non-operative side will be calculated by the formula: Improvement of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the non-operative side). The higher value means better imaging outcome.	From baseline to 3 months.
Secondary	Incidence of major adverse cerebral event ( MACE)	MACE contains ischemic or hemorrhagic stroke, crescendo TIAs evaluated by registered Neurologists.	From baseline to 3 months.
Secondary	The change of luminal area of superficial temporal artery	The luminal area of STA can reflect the angiogenesis induced by EDAS to some extent, and it will be measured by TOF-MRA.	From baseline to 3 months.
Secondary	The degree of the collaterals from superficial temporal artery	The degree of the collaterals from superficial temporal artery will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician. 0 for no collaterals from STA, 1 for little collaterals from STA, 2 for good collaterals from STA .	From baseline to 3 months.
Secondary	Volume of regions with hyperintense signal	Volume of regions with hyperintense signal where the maximum dimension should be larger than 8mm will be measured at axial T2, fluid-attenuated inversion recovery.	From baseline to 3 months.
Secondary	Number of regions with hyperintense signal	Number of regions with hyperintense signal will be counted at axial T2, fluid-attenuated inversion recovery.	From baseline to 3 months.
Secondary	RIC related Adverse events	Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms.	From baseline to 3 months.
Secondary	Flow velocity of superficial temporal artery at operative side	Flow velocity of superficial temporal artery at operative side will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician.	From baseline to 3 months.