Ignite Creation Date:
2024-05-06 @ 1:35 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04064658
Status:
SUSPENDED
Last Update Posted:
2019-09-19
First Post:
2019-08-20
Brief Title:
Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
Status:
SUSPENDED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
waiting for the ethics approval of collaborator affiliation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIME
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 revascularizationIn 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 11 ratio to RIPC group and sham RIPC group control Remote limb ischemic preconditioning RIPC is consisted of five 5-min cycles of bilateral arm ischemiareperfusion 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 ischemiareperfusion 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
DESIGNING About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 11 ratio to RIPC group and sham RIPC group control Remote limb ischemic preconditioning RIPC is consisted of five 5-min cycles of bilateral arm ischemiareperfusion 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 ischemiareperfusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None