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临床试验/NCT07033988
NCT07033988尚未招募不适用

Insights Into Cerebral Clot Biomarkers and Inflammatory Pathways

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
380
试验地点
1
主要终点
Assess the number of neutrophil extracellular traps (NETS)

研究概览

简要总结

This is an observational, prospective and retrospective, single-center study of thrombotic material and blood samples obtained from patients undergoing mechanical endovascular thrombectomy for ischemic stroke caused by large vessel occlusion or stenosis.

The overarching aim of this study is to advance the understanding of the pathogenesis of cerebral ischemia and to support the development of novel therapeutic strategies for cerebrovascular disease. Specifically, the research seeks to elucidate the pathophysiological mechanisms involved in thrombus formation and stabilization that lead to ischemic events, identify thrombus compositions associated with distinct stroke etiologies, and determine features predictive of resistance to current intravenous thrombolytic therapies. In addition, the study aims to discover novel therapeutic targets and to identify circulating blood biomarkers indicative of an elevated risk of thrombosis.

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

入选标准

  • Age ≥ 18 years.
  • Presentation to the emergency department with symptoms and/or signs suggestive of:
  • An acute cerebrovascular event
  • Stroke mimics
  • Stroke-related risk factors (e.g., atrial fibrillation, endocarditis, significant internal carotid stenosis, neoplasms, systemic infections)
  • Undergoing one of the following treatments:
  • Mechanical thrombectomy
  • Intravenous thrombolysis
  • Standard medical therapy
  • Provision of informed consent, either:
  • Directly from the conscious patient
  • Via appropriate procedures for unconscious patients

排除标准

  • Pregnancy or breastfeeding
  • Presence of a known autoimmune disease that could interfere with the interpretation of biomarker analyses

结局指标

主要结局

Assess the number of neutrophil extracellular traps (NETS)

时间窗: from 6/2025 to 5/2030

NETs will be quantified in thrombus tissue sections using immunofluorescence staining for citrullinated histone H3 and myeloperoxidase (MPO).

Quantification of leukocyte Infiltration in Thrombus

时间窗: 01.07.2025 up to 06.05.2030

Leukocyte will be quantified in thrombus sections using immunohistochemistry or immunofluorescence staining for neutrophil markers such as CD45, Cd11b, etc..

次要结局

  • Quantitative Analysis of Red Blood Cells, Fibrin, von Willebrand Factor, and Platelets in Thrombus.(01.08.2025 - 01-05-2030)
  • Quantification of Plasma Cytokine Levels in Ischemic Stroke Patients(01.08.2025 - 01.05.2030)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bacigaluppi Marco

Principal Investigator

IRCCS San Raffaele

研究点 (1)

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