Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients (RIME)

Capital Medical University

Status: Suspended

Conditions: Moyamoya Disease; Remote Ischemic Preconditioning

Treatments: Procedure: Remote ischemic preconditioning; Procedure: Sham remote ischemic preconditioning; Procedure: Encephaloduroarteriosynangiosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04064658

RIPC2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 328 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Sham RIPC group

Sham Comparator group

Description:

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

Treatment:

Procedure: Encephaloduroarteriosynangiosis

Procedure: Sham remote ischemic preconditioning

RIPC group

Experimental group

Description:

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

Treatment:

Procedure: Encephaloduroarteriosynangiosis

Procedure: Remote ischemic preconditioning