The Safety and Efficacy of RIC on Adult Moyamoya Disease

NCT04012268 | Completed

• 1 other identifier: RIC-AMD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moyamoya Disease

Keywords

moyamoya disease; remote ischemic conditioning; cerebral blood flow

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• incidence of ischemic stroke

  from the baseline to 12 months after treatment

• incidence of transient ischemic attack

  from the baseline to 12 months after treatment

• incidence of hemorrhagic stroke

  from the baseline to 12 months after treatment

• The level of matrix metalloproteinase 9 (MMP-9)

  change from the baseline to 3, 6, 12 months after treatment

• The level of vascular endothelial growth factor

  change from the baseline to 3, 6, 12 months after treatment

Study Arms (2)

RIC group

EXPERIMENTAL

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. They will also accept medication treatment by professional neurologists.

Device: RIC

Medication group

OTHER

Patients allocated to Medication group will accept medication treatment by professional neurologists.

Drug: Aspirin

Interventions

RIC DEVICE

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.

RIC group

Aspirin DRUG

patients will accept medication guided by neurologists

Medication group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Aspirin

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 9, 2019
• Study Start: July 15, 2019
• Primary Completion: November 10, 2020
• Study Completion: February 2, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

CN (1)