Acute Ischemic Stroke
Conditions
Keywords
Remote ischemic conditioning, anterior circulation, Acute Ischemic Stroke, Occlusion, stenosis
Brief summary
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.
Interventions
DEVICERIC
Remote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days.
DEVICESham
RIC is given twice a day with 60mmHg pressure, last for 7 to 10 days.
Guideline-based therapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age is 18 years old or above. 2. Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA). 3. Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset. 4. The NIHSS score ranges from 4 to 24. 5. The mRS score before stroke is less than or equal to 1. 6. informed consent.
Exclusion criteria
1. Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b). 2. Patients planning to receive intracranial endovascular treatment within 3 months. 3. Patients with cardiogenic embolism considered as the cause, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis, etc. 4. Patients diagnosed with acute posterior circulation cerebral infarction. 5. Symptoms caused by non - culprit vessels. 6. Ipsilateral extracranial vessel stenosis ≥ 70%. 7. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and uncontrollable by antihypertensive drugs. 8. Intracranial tumors, arteriovenous malformations or aneurysms. 9. Cerebral venous thrombosis or stenosis. 10. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days before enrollment. 11. Severe coagulation abnormalities. 12. Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc. 13. Patients with any serious diseases and a life expectancy of less than 1 year. 14. Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials. 15. Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.). 16. Pregnant or lactating women. 17. Patients who have previously received remote ischemic treatment or similar treatments. 18. Patients whom the researchers consider unsuitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of 90-day mRS scores | 90±14 days after procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with functional independence outcome (mRS 0-1) at 90-day | 90 (± 14 days) after procedure | 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) |
| Proportion of patients with functional independence outcome (mRS 0-2) at 90-day | 90 (± 14 days) after procedure | 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) |
| Proportion of patients with functional independence outcome (mRS 0-3) at 90-day | 90 (± 14 days) after procedure | 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) |
| Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study) | 90±14 days after procedure | 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 |
| Activities of Daily Living of Participants Assessed by Bathel Index at 90-day | 90 (± 14 days) after procedure | 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. |
| Activities of Daily Living of Participants Assessed by Bathel Index at 360-day | 360(± 14 days) after procedure | 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. |
| Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events | 360 (± 14 days) after procedure | 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. |
| The proportion of early neurological deterioration | 7 (± 1 day) after procedure | It is defined as an increase of ≥ 2 points in the NIHSS score on the 7th day compared to the baseline (excluding intracerebral hemorrhage). |
Countries
China
Contacts
Primary ContactWei Hu, MD, PhD
Outcome results
None listed