Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170944
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-12-05
Brief Title:
Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke
Sponsor:
General Hospital of Shenyang Military Region
Organization:
General Hospital of Shenyang Military Region
Study Overview
Official Title:
Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke RICAS a Prospective Randomized Blind Endpoint Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RICAS
Brief Summary:
The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology
Detailed Description:
Stroke is the second leading cause of death and the third leading cause of death and disability combined in the world The remote ischemic preconditioning RIC procedure is low-cost with excellent properties of safety tolerability and feasibility in both AIS and cardiovascular diseases In this study we aim to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology The RICAS study is a prospective randomized blind endpoint multicenter study Eligible patients with ischemic stroke of anterior circulation with large artery atherosclerosis etiology poor collateral compensation and more than 1 month of the symptom onset are randomly assigned into the experimental group and control group with a ratio of 11 The patients in experiment group will receive treatment with RIC for 1 year as an adjunct to guideline-based treatment while patients in control group only receive guideline-based treatment The primary outcome is proportion of collateral status improvement which is defined as an increase of ASITNSIR score of 1 or more assessed on DSA at 12 months after randomization The safety outcomes include RIC-related adverse events A maximum of 300 patients 150 participants per group are required to test the superiority hypothesis with 80 power using a two-sided α 005 to detect the 15 difference The primary endpoint will further be stratified by age gender inclusion event acute ischemic stroke ore transient ischemic stroke tandem lesion history of hypertension hypercholesterolemia diabetes mellitus ischemic stroke transient ischemic attack and myocardial infarction This study will provide the direct evidence for improvement of collateral status by chronic RIC treatment
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