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临床试验/NCT06954103
NCT06954103招募中不适用

Mechanisms And Prognosis of Stroke-Heart Syndrome

Chensheng Pan1 个研究点 分布在 1 个国家目标入组 658 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
658
试验地点
1
主要终点
blood high-sensitivity cardiac troponin level

研究概览

简要总结

The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.

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

  • •Patients admitted within 48 hours of onset, confirmed by CT/MRI as having a stroke (including acute ischemic stroke and hemorrhagic stroke).
  • •Moderate-to-severe stroke with NIHSS ≥ 5.

排除标准

  • •Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).
  • •Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).
  • •Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).
  • •History of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms).
  • •Concomitant systemic diseases such as renal failure (eGFR < 30), autoimmune disorders, severe infections, etc.
  • •History of dementia, depression, or other psychiatric disorders.
  • •Poor compliance and inability to cooperate with follow-up.

结局指标

主要结局

blood high-sensitivity cardiac troponin level

时间窗: within 48 hours and at 72 hours after stroke onset

a marker of acute myocardial injury

left ventricular ejection fraction

时间窗: within 1 week after stroke onset

measured by transthoracic echocardiography; a marker of ventricular dysfunction and heart failure

blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level

时间窗: within 1 week after stroke onset

a marker of ventricular dysfunction and heart failure

death

时间窗: 1 month, 3 months and 1 year after stroke onset

functional outcome

时间窗: 3 months and 1 year after stroke onset.

measured by modified Rankin scale (mRS), a 7-level ordinal scale (scores 0-6) used to assess global disability after stroke. Higher scores indicate worse functional outcome.

次要结局

  • post-stroke cognitive impairment(3 months and 1 year after stroke onset.)
  • post-stroke depression(3 months and 1 year after stroke onset.)
  • post-stroke anxiety(3 months and 1 year after stroke onset.)

研究者

发起方
Chensheng Pan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chensheng Pan

Professor

Tongji Hospital

研究点 (1)

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