NCT05800821Recruiting
Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 13 Mar 2023
- Start date
- 3 May 2023
- Primary completion date
- 3 May 2028
- Lead sponsor
- State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
- Diseases
- Stroke
- NCT number
- NCT05800821
What you commit to
- Study type: Observational
- Planned participants: 500
- From 3 May 2023 to the primary completion date, 3 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Epilepsy.
- History of traumatic brain injury.
- Demyelinating diseases of the central nervous system.
- History of neuroinfection.
- Chronic kidney disease with estimated glomerular filtration rate less than 45 mL/min/1.73 m².
Lab values
- Chronic heart failure with left ventricular ejection fraction less than 40%.
Other
- Systemic vasculitis.
- Cerebral vessel aneurysms.
- Arteriovenous malformation of the brain.
- Primary brain tumor (including metastatic lesions).
- Atrial fibrillation.
- Frequent supraventricular or ventricular extrasystoles.
- 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.
Who the study is looking for
- Age between 30 and 80 years.
- Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.
Age in the registry: 30 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| State Institution "Republican Scientific and Practical Center "Cardiology" Coordinator of this site? Confirm its status | Minsk | Belarus | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.