Status:
RECRUITING
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Stroke, Acute Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Acute ischemic stroke confirmed by NCCT or MRI;
- Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
- Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
- Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
- First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
- Signed informed consent.
Exclusion
- Pre-stroke disability (mRS≥3);
- Patients with disturbance of consciousness;
- Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
- Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
- Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
- Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
- Previous history of intracerebral hemorrhage within 1 year;
- Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
- Planned carotid or intracranial revascularization within 3 months;
- Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
- Cardiac insufficiency (NYHA Class ≥II);
- Pregnant or lactating women;
- Comorbidity with other serious diseases;
- Participating in other clinical trials within 3 months;
- Patients not suitable for the study considered by researcher.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06010641
Start Date
January 10 2024
End Date
October 30 2026
Last Update
March 18 2025
Active Locations (1)
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1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016