Clinical trial NCT04064658: Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients
Official title: Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Moyamoya Disease
Remote Ischemic Preconditioning
Keywords: Moyamoya Disease
Cerebrovascular Disorders
Arterial Occlusive Diseases
Ischemia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
First posted: 2019-08-22
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Cerebrovascular Events.
timeFrame: postoperative one month
measure: Number of Patients Dependent or Death
timeFrame: postoperative one month
Secondary outcomes:
measure: The Severity of the Ischemic Stroke after Surgery
timeFrame: postoperative one month
measure: Number of Patients Occured Re-stroke at Follow-up Period
timeFrame: 6 months and 12 months after EDAS
measure: Number of Patients Dependent or Death at Follow-up Period
timeFrame: 6 months and 12 months after EDAS
measure: Number of Patients with Improved Neurological Function at Follow-up Period
timeFrame: 6 months and 12 months after EDAS
measure: Perfusion Status of Patients at Follow-up Period
timeFrame: 6 months and 12 months after EDAS
measure: Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.
timeFrame: From baseline to 12 months after treatment
measure: Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.
timeFrame: Within 48 hours after EDAS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hosiptal
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yuanli Zhao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Rong Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: