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RECRUITING
NCT07889531
NA

Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). The primary research questions include: Does RIC lower the incidence of cerebral ischemic events (e.g., stroke, transient ischemic attack) compared to standard care? Does RIC slow disease progression, as measured by neuroimaging markers (e.g., cerebral blood flow, collateral vessel development) and clinical assessments? Does RIC improve long-term functional outcomes (e.g., modified Rankin Scale, quality of life) in this patient population? Study Design This is a multicenter, prospective, double-blind, randomized controlled trial (RCT). Eligible participants who provide informed consent and complete baseline evaluations will be dynamically randomized (1:1) via a central randomization system using the minimization method to either the intervention group or the control group. Intervention Group: Patients will receive RIC therapy (using an automated device) in addition to optimal medical treatment (OMT). RIC will be administered twice daily for 6 months, with each session consisting of 5 cycles of bilateral upper-limb cuff inflation (5 min at a preset high pressure) followed by deflation (5 min), totaling \~45 min per session. OMT includes antiplatelet agents, antihypertensives, antidiabetics, and lipid-lowering drugs as clinically indicated. Control Group: Patients will receive a sham RIC procedure (using the same device but with cuffs inflated to a fixed low pressure of 60 mmHg) alongside identical OMT. The frequency, duration, and cycling protocol will match those of the intervention group.

Official title: A Study on the Efficacy and Safety of Remote Ischemic Conditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2026-10-10

Completion Date

2027-12-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DEVICE

Standard Remote Ischemic Preconditioning

Patients in the intervention group receive remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using a unified RIC device, the treatment is administered twice daily for a total duration of 6 months. Each session consists of 5 cycles: after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to a preset high pressure (systolic blood pressure + 50 mmHg) for 5 minutes, followed by deflation for 5 minutes, with a total duration of approximately 45 minutes per session. The optimal medical therapy includes conventional treatments such as antiplatelet therapy, blood pressure control, glucose control, and lipid regulation.

DEVICE

Sham Remote Ischemic Preconditioning

Patients in the control group receive sham remote ischemic preconditioning (RIC) treatment on the basis of optimal medical therapy. Using the same RIC device, after bilateral upper arm blood pressure measurement, the upper arm cuffs are inflated to 60 mmHg. The treatment frequency, total duration, cycling protocol, and definition of the optimal medical therapy regimen are completely consistent with those of the intervention group.

Locations (1)

Titan Hospital; Capital Medical University

Beijing, Beijing Municipality, China