Local-to-Systemic Inflammatory Biomarker Gradients and 90-Day Functional Outcomes in Patients With Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion Undergoing Mechanical Thrombectomy: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Trans-Thrombus Interleukin-6 Gradient
研究概览
简要总结
The goal of this observational study is to describe the local change in interleukin-6 (IL-6) across a blood clot in adults with acute ischemic stroke caused by anterior circulation large vessel occlusion who are undergoing mechanical thrombectomy.
The main questions it aims to answer are:
- Is the level of IL-6 different in arterial blood collected beyond the clot compared with arterial blood collected before the clot during mechanical thrombectomy?
- Is the trans-thrombus IL-6 difference associated with functional independence 90 days after stroke and with complications related to reperfusion injury? There is no comparison group and no experimental treatment. Researchers will compare paired blood samples collected from opposite sides of the clot in the same participant. Blood collected from a peripheral vein at hospital admission will be used only as a supportive reference for systemic inflammation.
Participants will:
- Receive standard mechanical thrombectomy and stroke care determined by their treating clinical team.
- Have small blood samples collected at planned time points, including paired arterial blood samples collected during the thrombectomy procedure.
- Have clinical and imaging information collected from their medical records and have functional status assessed 90 days after stroke.
The study will not delay or change standard stroke treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or older.
- •Acute ischemic stroke caused by anterior circulation large vessel occlusion, confirmed by routine vascular imaging or digital subtraction angiography.
- •Undergoing clinically indicated mechanical thrombectomy according to routine clinical practice.
- •Provision of written informed consent by the participant or legally authorized representative, in accordance with local ethics requirements.
排除标准
- •Posterior circulation large vessel occlusion.
- •Mechanical thrombectomy not performed.
- •Known active systemic infection, active malignancy, or chronic inflammatory/autoimmune disease requiring systemic immunosuppressive treatment, when these conditions are expected to substantially affect inflammatory biomarker measurements.
- •Pregnancy or breastfeeding, if required by the local ethics committee.
- •Enrollment in another interventional study that could affect inflammatory biomarker measurements or clinical outcome assessment.
- •Inability to obtain informed consent, where consent from a legally authorized representative is not permitted or cannot be obtained.
研究组 & 干预措施
Prospective Mechanical Thrombectomy Cohort
Adults with acute ischemic stroke due to anterior circulation large vessel occlusion who undergo clinically indicated mechanical thrombectomy. All participants receive standard stroke care determined by the treating clinical team; no experimental intervention is assigned. Paired arterial blood samples are collected during thrombectomy from sites proximal and distal to the thrombus. A peripheral venous blood sample collected at hospital admission is used as a supportive systemic reference. Clinical, imaging, procedural, and 90-day functional outcome data are collected prospectively.
干预措施: Prospective Mechanical Thrombectomy Cohort (Other)
结局指标
主要结局
Trans-Thrombus Interleukin-6 Gradient
时间窗: During mechanical thrombectomy, before recanalization
The primary outcome is the within-participant trans-thrombus interleukin-6 (IL-6) gradient, defined as ln \[T2b/T2a\], where T2b is the IL-6 concentration in arterial plasma collected distal to the thrombus and T2a is the IL-6 concentration in arterial plasma collected proximal to the thrombus.
次要结局
- Good Function(90 (±14) days)
- Trans-Thrombus Interleukin-1 Beta Gradient(During mechanical thrombectomy, before recanalization)
- Trans-Thrombus Interleukin-17 Gradient(During mechanical thrombectomy, before recanalization)
- Functional independence(90 (±14) days)
- Trans-Thrombus Complement C3 Gradient(During mechanical thrombectomy, before recanalization)
- Trans-Thrombus Complement C5a Gradient(During mechanical thrombectomy, before recanalization)
- Trans-Thrombus Malondialdehyde Gradient(During mechanical thrombectomy, before recanalization)
- Trans-Thrombus Matrix Metalloproteinase-9 Gradient(During mechanical thrombectomy, before recanalization)
- Modified Rankin Score(90 (±14) days)
- Early neurological improvement(24 (±12) hours)
- Change in stroke severity(7 (±1) days or at discharge)
- Quality of life measured by EQ-5D-5L(90 (±14) days)
研究者
Xingyu Chen
Chief Physician, Department of Neurology
Zhongshan Hospital Xiamen University