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The reason for the early termination is that the results of the mediation analysis are inconclusive.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC group+Guideline-based therapy | Experimental | RIC is given twice a day with 200mmHg pressure. |
|
| Sham group+Guideline-based therapy | Active Comparator | RIC is given twice a day with 60mmHg pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIC | Device | Remote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90±14 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | China |
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| Sham | Device | RIC is given twice a day with 60mmHg pressure, last for 7 to 10 days. |
|
| Guideline-based therapy | Other | Guideline-based therapy |
|
| 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) | 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) | 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) | 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). | 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. | 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. | 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. | 360 (± 14 days) after procedure |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001733 | Bites and Stings |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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