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Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

Primary Purpose

Moyamoya Disease, Remote Ischemic Conditioning

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moyamoya Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    RIC group

    Control group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    the incidence of major neurologic complications during perioperative period

    Secondary Outcome Measures

    The Modified Rankin Scale (MRS) score

    Full Information

    First Posted
    May 6, 2023
    Last Updated
    May 6, 2023
    Sponsor
    Huashan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05860946
    Brief Title
    Remote Ischemic Conditioning in Adult Moyamoya Disease Patients
    Official Title
    Safety and Efficacy of Remote Ischemic Conditioning in Adult Moyamoya Disease Patients Undergoing Revascularization Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huashan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moyamoya Disease, Remote Ischemic Conditioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RIC group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Remote ischemic conditioning
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    the incidence of major neurologic complications during perioperative period
    Time Frame
    2 weeks after operation
    Secondary Outcome Measure Information:
    Title
    The Modified Rankin Scale (MRS) score
    Time Frame
    at 90 days postoperation and at 1 year after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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;

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

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