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Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

Safety and Efficacy of Remote Ischemic Conditioning in Adult Moyamoya Disease Patients Undergoing Revascularization Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05860946
Enrollment
44
Registered
2023-05-16
Start date
2023-08-01
Completion date
2024-12-01
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moyamoya Disease, Remote Ischemic Conditioning

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

Interventions

DEVICERemote ischemic conditioning

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

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Patients aged from 18 to 65 years old; 2. 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. 3. Modified Rankin Scale (mRS) score\<4; 4. Informed consent obtained from the patient or legally authorized representative.

Exclusion criteria

1. Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months; 2. Severe hepatic or renal dysfunction; 3. Severe cardiac disease; 4. Severe hemostatic disorder or severe coagulation dysfunction; 5. Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year; 6. Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;

Design outcomes

Primary

MeasureTime frame
the incidence of major neurologic complications during perioperative period2 weeks after operation

Secondary

MeasureTime frame
The Modified Rankin Scale (MRS) scoreat 90 days postoperation and at 1 year after operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026