Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients

Moyamoya Disease Clinical Trial

— RIME  

Official title:

Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04064658
• Other study ID #: RIPC2019
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2019
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 328
• Est. completion date: April 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Moyamoya Disease
• Remote Ischemic Preconditioning

Intervention

Procedure:
• 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.
• 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.
• Encephaloduroarteriosynangiosis
Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

Locations

Country	Name	City	State
China	Beijing Tiantan Hosiptal	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Cerebrovascular Events.	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.	postoperative one month
Primary	Number of Patients Dependent or Death	Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.	postoperative one month
Secondary	The Severity of the Ischemic Stroke after Surgery	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.	postoperative one month
Secondary	Number of Patients Occured Re-stroke at Follow-up Period	Re-stroke included ischemic stroke and hemorrhagic stroke.	6 months and 12 months after EDAS
Secondary	Number of Patients Dependent or Death at Follow-up Period	Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death.	6 months and 12 months after EDAS
Secondary	Number of Patients with Improved Neurological Function at Follow-up Period	The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores	6 months and 12 months after EDAS
Secondary	Perfusion Status of Patients at Follow-up Period	The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging	6 months and 12 months after EDAS
Secondary	Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.	The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS.	From baseline to 12 months after treatment
Secondary	Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.	The presence of =1 new brain lesions on DWI	Within 48 hours after EDAS