Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
2 other identifiers
observational
500
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedStudy Start
First participant enrolled
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 3, 2030
November 25, 2025
November 1, 2025
5 years
March 13, 2023
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Cerebral Hyperperfusion Syndrome
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
Study Arms (2)
Patients with Reduced Cerebrovascular Reserve
Patients with Sufficient Cerebrovascular Reserve
Interventions
Carotid revascularization
Eligibility Criteria
Patients who will undergo carotid revascularization procedures
You may qualify if:
- Age between 30 and 80 years.
- Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Institution "Republican Scientific and Practical Center "Cardiology"
Minsk, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Vascular Surgery Research Laboratory
Study Record Dates
First Submitted
March 13, 2023
First Posted
April 6, 2023
Study Start
May 3, 2023
Primary Completion (Estimated)
May 3, 2028
Study Completion (Estimated)
May 3, 2030
Last Updated
November 25, 2025
Record last verified: 2025-11