Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients

NCT ID: NCT04064658

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2024-04-01

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.

Conditions

Moyamoya Disease; Remote Ischemic Preconditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham RIPC group

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

Group Type: SHAM_COMPARATOR

Sham remote ischemic preconditioning

Intervention Type: PROCEDURE

Sham remote ischemic preconditioning 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.

Encephaloduroarteriosynangiosis

Intervention Type: PROCEDURE

Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

RIPC group

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

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: PROCEDURE

Remote ischemic preconditioning 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.

Encephaloduroarteriosynangiosis

Intervention Type: PROCEDURE

Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

Interventions

Remote ischemic preconditioning

Remote ischemic preconditioning 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.

Intervention Type: PROCEDURE

Sham remote ischemic preconditioning

Sham remote ischemic preconditioning 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.

Intervention Type: PROCEDURE

Encephaloduroarteriosynangiosis

Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

Intervention Type: PROCEDURE

Other Intervention Names

RIPC; Sham RIPC; EDAS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University International Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

yuanli Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuanli Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Rong Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hosiptal

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type: DERIVED

PMID: 36645250 (View on PubMed)

Other Identifiers

RIPC2019

Identifier Type: -

Identifier Source: org_study_id