NCT06740942招募中不适用
Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Autonomic dysfunction
研究概览
简要总结
The goal of this observational study is to
- to investigate the prevalence and time course of autonomic dysfunction in acute ischemic stroke patients;
- to evaluate the influence of lesion location on autonomic dysfunction;
- to identify patterns of structural and functional brain connectivity within the central autonomic control circuits associated with autonomic dysfunction; and
- to explore causal models of the link between brain lesions; cardiac, immunological and endocrine biomarkers; and dysautonomia.
Researchers will compare patients with acute ischemic stroke to patients with transient ischemic attacks to study the effect of acute ischemic brain lesions.
Participants will
- undergo cardiovascular autonomic function testing;
- receive structural and functional MR imaging;
- provide blood samples for determinaton of serological biomarkers auf dysautonomia.
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
- •Diagnosis of either
- •acute ischemic stroke with either an ischemic lesion visible on CT/MRI or persistent focal deficits 24 hours after symptom onset, or
- •Transient ischemic attack with transient clinical deficits including motor or speech disturbance and not restricted to isolated vertigo/dizziness, visual disturbance, or sensory disturbance.
- •symptom onset within 72h prior to hospital admission,
- •a pre-stroke/TIA ability to walk without help from another person (modified Rankin scale score < 4),
- •age > 18 years, and
- •informed consent by either the patient or a legal representative (including a spouse)
排除标准
- •In-hospital stroke,
- •contraindications to MR imaging (e.g., claustrophobia, pregnancy, pacemakers, implants),
- •known moderate to severe dementia,
- •previous structural brain damage (except leukoariosis due to cerebral small vessel disease),
- •hemodynamically relevant stenosis of the common or internal carotid artery, or
- •left heart failure with estimated left ventricular ejection fraction < 50%,
- •concomitant systemic illness that can lead to dysautonomia, such as an active infection, thyroid disease, or neurodegenerative disorder (e.g. PD, MSA).
结局指标
主要结局
Autonomic dysfunction
时间窗: 3-5 days after stroke onset
Cardiovagal and Adrenergic Scores on the Composite Autonomic Scoring Scale (0-7, higher values indicate greater dysfunction)
次要结局
- Autonomic dysfunction(90 days after stroke onset)
研究者
Eckhard Schlemm
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
研究点 (1)
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