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临床试验/NCT06265155
NCT06265155已完成不适用

Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion: A Case-crossover Study

Anzhi Li1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
302
试验地点
1
主要终点
RR values for exposure during the risk period versus exposure in the past year for each trigger

研究概览

简要总结

Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke.

详细描述

Stroke has a high lifetime risk worldwide and its morbidity and mortality are high. Among them, acute ischemic stroke caused by large vessel occlusion has serious condition and poor prognosis, which brings serious medical burden to individuals, families and society. Ischemic stroke includes various causes of cerebral blood supply disorders, leading to local brain ischemia, hypoxic necrosis, and rapid onset of corresponding neurological deficit symptoms. Its etiology includes vascular wall lesions, heart disease and hemodynamic changes, blood composition and hemorheological changes. Identified long-term risk factors for acute ischemic stroke include advanced age, male sex, race, hypertension, hypercholesterolemia, diabetes, smoking, sleep apnea, hyperhomocysteinemia, lifestyle, etc. Most of these risk factors are involved only in the development of acute ischemic stroke disease and do not directly contribute to the development of acute ischemic stroke.

The investigators aim was to gain insight into potential triggers in patients with acute ischemic stroke caused by large vessel occlusion in the short term before onset, and this trial intends to scientifically evaluate exposure to a range of potential triggers, including infection, extreme temperature changes, and several factors that increase blood pressure and their short-term risk of ischemic stroke through a multicenter, case-crossover study. Case-crossover study design is an epidemiological method used to investigate the instantaneous effects of transient exposure on acute illness, which has been widely used in heart disease, injury, car accidents and other research. The advantage of this method is that the use of the case itself as a control not only avoids the bias caused by the selection of the control, but also avoids the bias caused by some uncontrollable factors (such as age intelligence, genetics, etc.) between the cases. Exposure during the preictal risk period (exposure observed during the risk period) was asked about exposure to each trigger in the year preceding the onset of acute ischemic stroke. To assess the relative risk (RR) of ischemic stroke resulting from exposure to triggers and compare exposure during the risk period with the usual frequency of exposure. Exposure in the past year and mean exposure in the past year (assessed as chronic risk factors) and time to last exposure (assessed as triggers), estimated relative risks (RRs) and corresponding 95% CIs, assessed short-term risk of acute ischemic stroke due to large vessel occlusion by multiple triggers.

Previous studies of acute ischemic stroke triggers have found that negative mood, anger, and sudden changes in body posture in response to startle events appear to be independent triggers of ischemic stroke, and infectious syndromes may also be associated with an increased risk of stroke. Hemorrhagic stroke can be triggered by several triggers associated with acute, short-term blood pressure surges, including caffeine intake, minor head trauma, sexual activity, straining to defecate, lifting weights, strenuous physical exercise, fever, and flu-like illness. In addition, the triggers of intracranial aneurysm rupture and stroke in young adults have also been further clarified. Several possible biological explanations exist for how triggers increase stroke risk. First, some triggers, such as caffeine intake, certain types of drugs, sexual activity, and strenuous physical exercise, briefly raise blood pressure. Elevated blood pressure may lead to increased shear stress on the arterial vessel wall, potentially leading to disruption of the endothelial cell surface, which may increase the risk of thrombotic occlusion, particularly in combination with hypercoagulability caused by intense physical exercise. Therefore, an in-depth understanding of the potential triggers of acute ischemic stroke resulting from large vessel occlusion may not only improve the understanding of the pathophysiology of acute ischemic stroke, but may also provide new insights into its prevention and diagnosis and treatment methods.

研究设计

研究类型
Observational
观察模型
Case Crossover
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
  • imaging diagnosis of large vessel occlusion
  • CT excluded intracranial hemorrhage
  • signed informed consent form by the patient himself or his legal representative

排除标准

  • severe bleeding or known significant bleeding tendency
  • severe organ dysfunction
  • life expectancy of less than 90 days
  • presence of other conditions that the investigator considers inappropriate for enrollment

结局指标

主要结局

RR values for exposure during the risk period versus exposure in the past year for each trigger

时间窗: up to 24 hours

RR values for exposure during the risk period versus exposure in the past year for each trigger

次要结局

未报告次要终点

研究者

发起方
Anzhi Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anzhi Li

Resident Physician

Suzhou Municipal Hospital of Anhui Province

研究点 (1)

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