Clinical trial NCT05099354: The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke
Official title: The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke - a Prospective Descriptive Pilot Study (AFFRICATE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autonomic Nervous System
Keywords: stroke
thrombectomy
autonomic nervous system
Lead sponsor: Karl Landsteiner University of Health Sciences
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients treated with thrombectomy at the University Hospital Tulln during a period of 12 months, meeting inclusion and exclusion criteria will be included in the study.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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 3.
* Informed consent by the patient

Exclusion Criteria:

* 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

Primary outcomes:
measure: heart rate variability
timeFrame: change in baseline after 3 months
measure: baro receptor sensitivity
timeFrame: change in baseline after 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: