NCT06010641招募中不适用
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial
General Hospital of Shenyang Military Region1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年1月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- proportion of favorable functional outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Head-down position
Experimental
head-down position as an adjunct to guideline-based treatment
干预措施: head-down position (Other)
control
Other
guideline-based treatment
干预措施: head-down position (Other)
结局指标
主要结局
proportion of favorable functional outcome
时间窗: 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
次要结局
- new stroke or other vascular event(s)(90±7 days)
- early neurological deterioration (END)(48±12 hours)
- changes in infarct volume(48±12 hours)
- proportion of excellent functional outcome(90±7 days)
- ordinal distribution of modified Rankin Score (mRS)(90±7 days)
- early neurological improvement (ENI)(48±12 hours)
- Changes in National Institute of Health stroke scale (NIHSS)(10±2 days)
- all-cause mortality(90±7 days)
- Changes in National Institute of Health stroke scale (NIHSS)(48±12 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (1)
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