Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

Recruiting

• Conditions: Carotid Artery Diseases; Cerebral Hyperperfusion Syndrome; Carotid Atherosclerosis; Carotid Artery Stenosis
• Interventions: Procedure: Carotid revascularization

• Registration Number: NCT05800821
• Lead Sponsor: State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Brief Summary

Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical syndrome following carotid endarterectomy (CEA), but it may present in both CEA and carotid artery stenting, and is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and face pain, vomiting, confusion, macular oedema, and visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.

Knowledge of CHS among physicians is limited. Most studies report incidences of CHS of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in perfusion compared with baseline after carotid revascularization procedures and is rare in patients with increases in perfusion less than 100% compared with baseline.

The pathophysiological mechanism of CHS remains only partially understood. The chronic lowflow state induced by severe carotid disease results in a 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. In fact, it has been shown that this dysautoregulation is proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, the impaired cerebral autoregulation could then contribute to a cascade of intracranial microcirculatory changes, as explained above, with an inability of reaction toward the augmentation of the CBF after the carotid recanalization.

Although most patients have mild symptoms and signs, progression to severe and life-threatening symptoms can occur if CHS is not recognised and treated adequately. Because CHS is a diagnosis based on several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications like thromboembolism.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-06
• Study Start: 2023-05-03
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-05-03
• Study Completion: 2030-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Age from 30 to 80 years
2. Has a symptomatic (more than 60%) or a asymptomatic (more than 70%) carotid stenosis
3. Permanent residence in the Republic of Belarus

Exclusion Criteria

1. Patient's unwillingness to continue participating in the study
2. Absence of a temporal window for transcranial dopplerography

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with sufficient cerebrovascular reserve	Carotid revascularization	-
Patients with reduced cerebrovascular reserve	Carotid revascularization	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Cerebral Hyperperfusion Syndrome	within 30 days after surgery	The diagnosis of cerebral hyperperfusion syndrome will be based on the following criteria: 1. The 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, signs of cerebral edema or intracerebral hemorrhage.; 3. Symptoms of the "luxury perfusion syndrome" in the first 24-48 hours after the restoration of blood flow through the internal carotid artery.; 4. Increase in cerebral blood flow in the middle cerebral artery \> 100% compared to the preoperative value measured by transcranial dopplerography.; 5. Hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome and reversible cerebral vasoconstriction syndrome are excluded.; 6. Neurological symptoms appeared on the background of high blood pressure.

Trial Locations

Locations (1)

State Institution "Republican Scientific and Practical Center "Cardiology"; 🇧🇾 Minsk, Belarus