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

NCT04917003 | Unknown DMC

• 1 other identifier: RIC-IMD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moyamoya Disease

Keywords

moyamoya disease; EDAS; remote ischemic conditioning; cerebral blood flow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• the change of TTP delay at operative side

  From baseline to 3 months.

• rCBF changed ratio at non-operative side

  From baseline to 3 months.

• the change of TTP delay at non-operative side

  From baseline to 3 months.

• Incidence of major adverse cerebral event ( MACE)

  From baseline to 3 months.

• The change of luminal area of superficial temporal artery

  From baseline to 3 months.

Study Arms (2)

RIC group

EXPERIMENTAL

Patients who are allocated into RIC group will undergo the first EDAS surgery combined 3-month remote ischemic conditioning (RIC) treatment. The opposite operation will be performed at 3 months after the first operation. RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used.

Other: RIC plus EDAS

control group

OTHER

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. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. Under certain circumstances, depending on the territory at risk, the occipital artery was also used. The donor vessel with the strip of galea (the arterial bridge) was detached from the pericranium or the fascia below, and two burr holes are made beneath the proximal and distal ends of the arterial bridge. The burr holes, with an average size of 3.0 × 8.0 cm, were connected by mill to make an oval bone flap and the dura was exposed. The target artery was then sewn to the dura using 10-0 Prolene suture. The bone flap was closed after cutting out the entry and exit sites for the target artery.

Other: EDAS

Interventions

RIC plus EDAS OTHER

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.

RIC group

EDAS OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Suzuki stage: 2-5 stage
• Age: between 18 and 65 years old
• Subjects present with ischemic stroke or transient ischemic attack.
• Subjects who plan to accept the first EDAS surgery.
• Informed consent obtained from patient or patient's surrogate

You may not qualify if:

• Acute ischemic stroke occurred within one month.
• Suffered Intracranial hemorrhage before
• Subjects with large infarction spread widely over the territory of a main arterial trunk
• Aneurysms in the main arterial trunk
• Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on.
• Malignant tumors or severe disordered function of the heart, lung, liver or kidney.
• Severe hemostatic disorder or severe coagulation dysfunction.
• 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.
• Severe injury on upper limbs.
• Pregnant or lactating women.
• Life expectancy is less than 3 years.
• Patients who are not suitable for this trial considered by researchers for other reasons

Sponsors & Collaborators

• Capital Medical University: lead
• Beijing 302 Hospital: collaborator

Study Sites (1)

The 307th Hospital of the Chinese People's Liberation Army

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xunming Ji, PhD

CONTACT

861013120136877; jixunming@vip.163.com

Jiali Xu, MD

CONTACT

010-18800117908; m18800117908@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: June 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

CN (1)