Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

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 Overview

Study Type

Observational

Enrollment (Estimated)

500

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

Study Contact Backup

  • Name: Henadzi Popel
  • Phone Number: +375291759336
  • Email: hpopel@mail.ru

Study Locations

      • Minsk, Belarus
        • Recruiting
        • State Institution "Republican Scientific and Practical Center "Cardiology"
        • Contact:
        • 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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who will undergo carotid revascularization procedures

Description

Inclusion Criteria:

  1. Age between 30 and 80 years.
  2. Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.

Exclusion Criteria:

  1. Systemic vasculitis.
  2. Cerebral vessel aneurysms.
  3. Arteriovenous malformation of the brain.
  4. Primary brain tumor (including metastatic lesions).
  5. Epilepsy.
  6. History of traumatic brain injury.
  7. Demyelinating diseases of the central nervous system.
  8. History of neuroinfection.
  9. Atrial fibrillation.
  10. Frequent supraventricular or ventricular extrasystoles.
  11. Chronic heart failure with left ventricular ejection fraction less than 40%.
  12. Chronic kidney disease with estimated glomerular filtration rate less than 45 mL/min/1.73 m².
  13. Presence of an implanted cardioverter-defibrillator or pacemaker.
  14. Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.
  15. Patient's unwillingness to continue participating in the study.
  16. Absence of a temporal acoustic window for transcranial Doppler ultrasonography.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Reduced Cerebrovascular Reserve
Carotid revascularization
Patients with Sufficient Cerebrovascular Reserve
Carotid revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Occurrence of symptoms within 30 postoperative days

Collaborators and Investigators

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

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 (Actual)

May 3, 2023

Primary Completion (Estimated)

May 3, 2028

Study Completion (Estimated)

May 3, 2030

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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