NCT05099354

The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke

The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke - a Prospective Descriptive Pilot Study (AFFRICATE)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Karl Landsteiner University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Autonomic Nervous System

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	autonomic nervous system testing	* Autonomic tests, including heart rate variability (HRV) and baroreceptor sensitivity (BRS), are performed with a 10min ECG with non-invasive or invasive blood pressor measuring during rest. During the time at the stroke unit, this data will be calculated using the existing continuous monitoring. * Valsalva maneuver during continuous ECG and blood pressure monitoring. The patient will be instructed to exhale against a mouthpiece with a defined resistance for 15 seconds. * Assessment of the cerebrovascular reserve capacity will be done with continuous transcranial duplex sonography (TCD) and "breath holding index" (BHI). The patient will be instructed to hold his breath for 30 seconds, 4 times in a row with intervals of 4 minutes. This test will be performed only in responsive and compliant patients.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2021-10-29
• Last updated: 2021-10-29