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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05099354
Acronym
AFFRICATE
Enrollment
20
Registered
2021-10-29
Start date
2021-10-31
Completion date
2022-12-31
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System

Keywords

stroke, thrombectomy, autonomic nervous system

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.

Interventions

DIAGNOSTIC_TESTautonomic 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.

Sponsors

Karl Landsteiner University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
heart rate variabilitychange in baseline after 3 monthsheart rate variability measured by 30 minute continuous ecg
baro receptor sensitivitychange in baseline after 3 monthscalculated from continuous ecg and continuous non-invasive blood pressure over 30 minutes

Contacts

Primary ContactElisabeth Olbert, Dr.
elisabeth.olbert@tulln.lknoe.at+432272900427650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026