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

October 18, 2021 updated by: Karl Landsteiner University of Health Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate variability
Time Frame: change in baseline after 3 months
heart rate variability measured by 30 minute continuous ecg
change in baseline after 3 months
baro receptor sensitivity
Time Frame: change in baseline after 3 months
calculated from continuous ecg and continuous non-invasive blood pressure over 30 minutes
change in baseline after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Landsteiner University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFFRICATEThrombectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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