Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)
Study Details
Study Description
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 atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Head-down position head-down position as an adjunct to guideline-based treatment |
Other: head-down position
-20° Trendelenburg as an adjunct to guideline-based treatment,
|
| Other: control guideline-based treatment |
Other: head-down position
-20° Trendelenburg as an adjunct to guideline-based treatment,
|
Outcome Measures
Primary Outcome Measures
- proportion of favorable functional outcome [90±7 days]
favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Secondary Outcome Measures
- proportion of excellent functional outcome [90±7 days]
excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
- ordinal distribution of modified Rankin Score (mRS) [90±7 days]
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
- early neurological deterioration (END) [48±12 hours]
END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
- early neurological improvement (ENI) [48±12 hours]
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
- Changes in National Institute of Health stroke scale (NIHSS) [48±12 hours]
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
- Changes in National Institute of Health stroke scale (NIHSS) [10±2 days]
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
- changes in infarct volume [48±12 hours]
- new stroke or other vascular event(s) [90±7 days]
- all-cause mortality [90±7 days]
Other Outcome Measures
- changes in cortical oxygen saturation determined by near infrared spectroscopy [24±8 hours]
- changes in cortical oxygen saturation determined by near infrared spectroscopy [48±12 hours]
- changes in serum biomarkers [48±12 hours]
- changes in serum biomarkers [10±2 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
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Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
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First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
-
Signed informed consent.
Exclusion Criteria:
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Pre-stroke disability (mRS≥3);
-
Patients with disturbance of consciousness;
-
Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
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Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
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Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
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Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
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Previous history of intracerebral hemorrhage within 1 year;
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Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
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Planned carotid or intracranial revascularization within 3 months;
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Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
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Cardiac insufficiency (NYHA Class ≥II);
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Pregnant or lactating women;
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Comorbidity with other serious diseases;
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Participating in other clinical trials within 3 months;
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Patients not suitable for the study considered by researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, General Hospital of Northern Theater Command | Shenyang | China | 110016 |
Sponsors and Collaborators
- General Hospital of Shenyang Military Region
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Y (2023) 148