Autonomic Nervous SystemAFFRICATENCT05099354
The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke
An observational study of Autonomic Nervous System, run by Karl Landsteiner University of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Nervous System
- What is being tested?
- autonomic nervous system testing
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- Patent foramen ovale in the medical history.
- Glaucoma in medical history.
- Inability to complete study visits
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Autonomic Nervous System
- Being tested
- autonomic nervous system testing
- Keywords
- stroke, thrombectomy, autonomic nervous system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autonomic nervous system testingDiagnostic test
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
heart rate variability measured by 30 minute continuous ecg
Measured: change in baseline after 3 months
baro receptor sensitivity
calculated from continuous ecg and continuous non-invasive blood pressure over 30 minutes
Measured: change in baseline after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099354
- Sponsor's protocol ID
- AFFRICATEThrombectomy
- Acronym
- AFFRICATE
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endovascular Thrombectomy on Autonomic Nervous System in Patients With Large-vessel Ischemic Stroke - a Prospective Descriptive Pilot Study (AFFRICATE)
- ClinicalTrials.gov ID
- NCT05099354
- Acronym / sponsor ID
- AFFRICATE / AFFRICATEThrombectomy
- Conditions
- Autonomic Nervous System
- Keywords
- stroke, thrombectomy, autonomic nervous system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
heart rate variability
Time frame: change in baseline after 3 months
heart rate variability measured by 30 minute continuous ecg
baro receptor sensitivity
Time frame: change in baseline after 3 months
calculated from continuous ecg and continuous non-invasive blood pressure over 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System, run by Karl Landsteiner University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Olbert, Dr. (+432272900427650, elisabeth.olbert@tulln.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: change in baseline after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.