Moyamoya Disease Clinical Trial
Official title:
Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
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.
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