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.
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 1:1. 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 ASITN/SIR 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 = 0.05) 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.
General Hospital of Northern Theater Command
Shenyang, China
RECRUITINGThe proportion of collateral status improvement.
collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.
Time frame: 12 months
The influence of RIC to neurological functions
Neurological functions was determined by modified Rankin Scale score (0-42, higher scores mean a worse outcome )
Time frame: 12 months
Recurrence of nonfatal ischemic stroke in 12 months
Ischemic stroke is diagnosed based on clinical symptom and neuroimaging
Time frame: 12 months
Composite vascular events
Composite vascular events include stroke, myocardial infarction, vascular death
Time frame: 12 months
Influence on heart function
heart function is assessed by cardiac ultrasound, electrocardiogram, myocardial enzyme profile, etc
Time frame: 12 months
Influence on kidney function
kidney function is assessed by glomeruar filtration rate
Time frame: 12 months
RIC-related adverse events
include local pain, intolerance, etc.
Time frame: 12 months
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