Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients

Not Applicable

Suspended

• Conditions: Moyamoya Disease; Remote Ischemic Preconditioning
• Interventions: Procedure: Remote ischemic preconditioning; Procedure: Sham remote ischemic preconditioning; Procedure: Encephaloduroarteriosynangiosis

• Registration Number: NCT04064658
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).

Detailed Description

BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.

DESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Study Start: 2019-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

1. Patients who diagnosed with moyamoya disease
2. Adults 18 to 65 years of age
3. The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)
4. Able to receive the necessary imaging examination
5. Patients who pre-agreed to the study

Exclusion Criteria

1. Prior cerebral hemorrhage history
2. Other brain or cerebrovascular disease
3. Previous history of revascularization surgery
4. Dependent (mRS > 2)
5. Receive other type of revascularization surgery
6. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
7. Patients who do not agree with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC group	Encephaloduroarteriosynangiosis	Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis
Sham RIPC group	Encephaloduroarteriosynangiosis	Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis
RIPC group	Remote ischemic preconditioning	Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis
Sham RIPC group	Sham remote ischemic preconditioning	Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis

Primary Outcome Measures

Name	Time	Method
Number of Patients Dependent or Death	postoperative one month	Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.
Number of Patients With Cerebrovascular Events.	postoperative one month	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Occured Re-stroke at Follow-up Period	6 months and 12 months after EDAS	Re-stroke included ischemic stroke and hemorrhagic stroke.
Number of Patients Dependent or Death at Follow-up Period	6 months and 12 months after EDAS	Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.
The Severity of the Ischemic Stroke after Surgery	postoperative one month	The severity of the ischemic stroke was evaluated by the white matter hyperintensities volume on the MRI, the neurological deficits duration and the Modified Rankin Scale (mRS) of patients.
Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.	From baseline to 12 months after treatment	The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS.
Number of Patients with Improved Neurological Function at Follow-up Period	6 months and 12 months after EDAS	The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores
Perfusion Status of Patients at Follow-up Period	6 months and 12 months after EDAS	The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging
Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.	Within 48 hours after EDAS	The presence of ≥1 new brain lesions on DWI

Trial Locations

Locations (2)

Beijing Tiantan Hosiptal; 🇨🇳 Beijing, Beijing, China

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China