Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

NCT05860946 | Unknown DMC

• 1 other identifier: HS9126
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy

Conditions

Moyamoya Disease; Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

• the incidence of major neurologic complications during perioperative period

  2 weeks after operation

Secondary Outcomes (1)

• The Modified Rankin Scale (MRS) score

  at 90 days postoperation and at 1 year after operation

Study Arms (2)

RIC group

EXPERIMENTAL

Patients in RIC group and control group will achieve RIC intervention and sham RIC intervention three times daily from 5 days before operation and 7 days post operation

Device: Remote ischemic conditioning

Control group

SHAM COMPARATOR

Patients in control group, bilateral upper arm cuffs were inflated to a pressure of 60 mm Hg for 5 minutes, followed by 5 minutes of relaxation of the cuffs

Device: Remote ischemic conditioning

Interventions

Remote ischemic conditioning DEVICE

The RIC intervention included five cycles of 5 min inflating tourniquets with the pressure of 200 mmHg and 5 min deflating with pressure of 0 mmHg alternately

Control group; RIC 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:

• Patients aged from 18 to 65 years old;
• Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in 201211.
• Modified Rankin Scale (mRS) score\<4;
• Informed consent obtained from the patient or legally authorized representative.

You may not qualify if:

• Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
• Severe hepatic or renal dysfunction;
• Severe cardiac disease;
• Severe hemostatic disorder or severe coagulation dysfunction;
• Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year;
• Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;

Sponsors & Collaborators

• Huashan Hospital: lead

Related Publications (1)

• Yang H, Hu Z, Gao X, Su J, Jiang H, Yang S, Zhang Q, Ni W, Gu Y. Safety and efficacy of remote ischemic conditioning in adult moyamoya disease patients undergoing revascularization surgery: a pilot study. Front Neurol. 2023 Jul 28;14:1200534. doi: 10.3389/fneur.2023.1200534. eCollection 2023.

  PMID: 37576009 DERIVED

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

Study Design

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

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share