The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Distribution of 90-day mRS scores
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Time frame: 90±14 days after procedure
Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
Time frame: 90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-3) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
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Time frame: 90 (± 14 days) after procedure
The proportion of early neurological deterioration
It is defined as an increase of ≥ 2 points in the NIHSS score on the 7th day compared to the baseline (excluding intracerebral hemorrhage).
Time frame: 7 (± 1 day) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 90-day
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
Time frame: 90 (± 14 days) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 360-day
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
Time frame: 360(± 14 days) after procedure
Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events
Adverse cardiovascular and cerebrovascular events include myocardial infarction, heart failure, severe arrhythmia, cerebral infarction, cerebral hemorrhage, transient ischemic attack (TIA), and recurrent ischemic events include recurrent myocardial infarction and recurrent cerebral infarction.
Time frame: 360 (± 14 days) after procedure