Clinical trial NCT06823128: Safety and Efficacy of Remote Ischemic Conditioning in Patients with Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Patients with Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Remote ischemic conditioning
anterior circulation
Acute Ischemic Stroke
Occlusion
stenosis
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Distribution of 90-day mRS scores
timeFrame: 90±14 days after procedure
Secondary outcomes:
measure: Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)
timeFrame: 90±14 days after procedure
measure: Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
timeFrame: 90 (± 14 days) after procedure
measure: Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
timeFrame: 90 (± 14 days) after procedure
measure: Proportion of patients with functional independence outcome (mRS 0-3) at 90-day
timeFrame: 90 (± 14 days) after procedure
measure: The proportion of early neurological deterioration
timeFrame: 7 (± 1 day) after procedure
measure: Activities of Daily Living of Participants Assessed by Bathel Index at 90-day
timeFrame: 90 (± 14 days) after procedure
measure: Activities of Daily Living of Participants Assessed by Bathel Index at 360-day
timeFrame: 360(± 14 days) after procedure
measure: Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events
timeFrame: 360 (± 14 days) after procedure
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
Study officials:
References: