Carotid Artery DiseasesNCT05800821
Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
An observational study of Carotid Artery Diseases and Carotid Atherosclerosis, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
Trial summary
Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Stenosis
- What is being tested?
- Carotid revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteBelarus
- Study dates
- 3 May 2023to 3 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo carotid revascularization procedures
Who may be able to join
- Age between 30 and 80 years.
- Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.
Who cannot join
- Systemic vasculitis.
- Cerebral vessel aneurysms.
- Arteriovenous malformation of the brain.
- Primary brain tumor (including metastatic lesions).
- Epilepsy.
- History of traumatic brain injury.
Show all 16Show fewer
- Demyelinating diseases of the central nervous system.
- History of neuroinfection.
- Atrial fibrillation.
- Frequent supraventricular or ventricular extrasystoles.
- Chronic heart failure with left ventricular ejection fraction less than 40%.
- Chronic kidney disease with estimated glomerular filtration rate less than 45 mL/min/1.73 m².
- Presence of an implanted cardioverter-defibrillator or pacemaker.
- Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.
- Patient's unwillingness to continue participating in the study.
- Absence of a temporal acoustic window for transcranial Doppler ultrasonography.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site, 1 recruiting
- Recruiting
State Institution "Republican Scientific and Practical Center "Cardiology"
Minsk
Ivan Maiseyenka, +375333288850, i_a_moiseenko@mail.ru
Henadzi Popel, +375291759336, hpopel@mail.ru
About this study
Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.
Knowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.
Read more
The pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.
Although most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.
- Conditions
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Stenosis, Cerebral Hyperperfusion Syndrome
- Being tested
- Carotid revascularization
- Keywords
- Cerebral Hyperperfusion Syndrome, Carotid Stenosis, Stroke, Deep Learning
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid revascularizationProcedure or surgery
Carotid revascularization
| Study group | Role | What they receive |
|---|---|---|
| Patients with Reduced Cerebrovascular Reserve | Not described Receives: Procedure: Carotid revascularization | |
| Patients with Sufficient Cerebrovascular Reserve | Not described Receives: Procedure: Carotid revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Cerebral Hyperperfusion Syndrome
The diagnosis of cerebral hyperperfusion syndrome will be based on the following criteria:
- Appearance of symptoms within 1 month after surgery.
- First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, Glasgow Coma Scale score < 15 points, aphasia, or signs of cerebral edema or intracerebral hemorrhage.
- Symptoms of "luxury perfusion syndrome" occurring within the first 24-48 hours after restoration of blood flow through the internal carotid artery.
- Increase in cerebral blood flow in the middle cerebral artery > 100% compared with the preoperative value, measured by transcranial Doppler ultrasonography.
- Exclusion of differential diagnoses, including hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome, and reversible cerebral vasoconstriction syndrome.
- Neurological symptoms occurring in the context of high blood pressure.
Measured: Occurrence of symptoms within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start3 May 2023
- Primary completion3 May 2028 (estimated)
- Study completion3 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ivan Maiseyenka, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800821
- Sponsor's protocol ID
- 455
- Other IDs
- 20251402/497
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
- ClinicalTrials.gov ID
- NCT05800821
- Acronym / sponsor ID
- 455
- Conditions
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Stenosis, Cerebral Hyperperfusion Syndrome
- Keywords
- Cerebral Hyperperfusion Syndrome, Carotid Stenosis, Stroke, Deep Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, BelarusUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 May 2028 (estimated)
- Study completion
- 3 May 2030 (estimated)
- First posted
- 6 Apr 2023 (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.
Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.
Knowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.
The pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.
Although most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Reduced Cerebrovascular Reserve | – | Procedure: Carotid revascularization |
| Patients with Sufficient Cerebrovascular Reserve | – | Procedure: Carotid revascularization |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo carotid revascularization procedures
Key inclusion criteria (2 listed)
- Age between 30 and 80 years.
- Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.
Key exclusion criteria (16 listed)
- Systemic vasculitis.
- Cerebral vessel aneurysms.
- Arteriovenous malformation of the brain.
- Primary brain tumor (including metastatic lesions).
- Epilepsy.
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 |
|---|---|---|
| Carotid revascularizationCarotid revascularization | Procedure or surgery | Patients with Reduced Cerebrovascular Reserve, Patients with Sufficient Cerebrovascular Reserve |
Primary outcome
Number of Participants with Cerebral Hyperperfusion Syndrome
Time frame: Occurrence of symptoms within 30 postoperative days
The diagnosis of cerebral hyperperfusion syndrome will be based on the following criteria: 1. Appearance of symptoms within 1 month after surgery. 2. First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, Glasgow Coma Scale score < 15 points, aphasia, or signs of cerebral edema or intracerebral hemorrhage. 3. Symptoms of "luxury perfusion syndrome" occurring within the first 24-48 hours after restoration of blood flow through the internal carotid artery. 4. Increase in cerebral blood flow in the middle cerebral artery > 100% compared with the preoperative value, measured by transcranial Doppler ultrasonography. 5. Exclusion of differential diagnoses, including hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome, and reversible cerebral vasoconstriction syndrome. 6. Neurological symptoms occurring in the context of high blood pressure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Carotid Atherosclerosis, run by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus at 1 site in Belarus.
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 2 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Maiseyenka (+375333288850, i_a_moiseenko@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Cerebral Hyperperfusion Syndrome (time frame: Occurrence of symptoms within 30 postoperative days). 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 25 Nov 2025.