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NCT Number: NCT05800821

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Systemic vasculitis.
  • Cerebral vessel aneurysms.
  • Arteriovenous malformation of the brain.
  • Primary brain tumor (including metastatic lesions).
  • Epilepsy.
  • History of traumatic brain injury.
  • 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.

Treatment and study plan

Carotid revascularization

Procedure

Carotid revascularization

Primary outcomes

  1. 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:

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Henadzi Popel

CONTACT

[email protected]

+375291759336

Ivan Maiseyenka

CONTACT

[email protected]

+375333288850

Sponsors and collaborators

Lead sponsor

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Apr 6, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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