The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke - a Prospective Descriptive Pilot Study (AFFRICATE)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- heart rate variability
研究概览
简要总结
The autonomic nervous system (ANS), regulating involuntary physiologic processes including heart rate and blood pressure, is affected by changes in the cerebral vessels like carotid artery stenosis, occlusion, carotid artery stent and endarterectomy.
Until now, no data concerning autonomic nervous system in patients with acute intracranial large artery occlusion and thrombectomy is available. Due to the known effect on ANS in case of pathologies of extracranial brain supplying arteries it is highly suspected that intracranial large artery occlusion and thrombectomy can affect the ANS as well.
The aim of this project is to determine autonomic parameters during and after thrombectomy in patients with large cerebral artery occlusion. The project is a prospective descriptive pilot study at the University Hospital Tulln. 20 patients will be assessed during and after thrombectomy up to three months post intervention. A combination of autonomic parameters, hemodynamic parameters and clinical outcome will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 of age
- •Acute ischemic stroke with large extra- and intracranial artery occlusion and intraarterial mechanical thrombectomy treatment.
- •Successful recanalization after thrombectomy with TICI 2b or
- •Informed consent by the patient
排除标准
- •Informed consent not possible within 7 days after thrombectomy due to impaired awareness or speech disturbances.
- •Permanent stent during thrombectomy.
- •Severe complications, such as severe intracranial hemorrhage, during or after thrombectomy including prolonged ICU stay.
- •Modified rankin scale (mRS) over 3 before admission.
- •Diagnosis of dementia with mini mental state examination (MMSE) < 26 points in the medical history
- •Intracranial hypertension in the medical history or brain imaging.
- •Patent foramen ovale in the medical history.
- •Glaucoma in medical history.
- •Inability to complete study visits
结局指标
主要结局
heart rate variability
时间窗: change in baseline after 3 months
heart rate variability measured by 30 minute continuous ecg
baro receptor sensitivity
时间窗: change in baseline after 3 months
calculated from continuous ecg and continuous non-invasive blood pressure over 30 minutes
次要结局
未报告次要终点