- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ivan Maiseyenka
- Phone Number: +375333288850
- Email: i_a_moiseenko@mail.ru
Study Contact Backup
- Name: Henadzi Popel
- Phone Number: +375291759336
- Email: hpopel@mail.ru
Study Locations
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-
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Minsk, Belarus
- Recruiting
- State Institution "Republican Scientific and Practical Center "Cardiology"
-
Contact:
- Ivan Maiseyenka
- Phone Number: +375333288850
- Email: i_a_moiseenko@mail.ru
-
Contact:
- Henadzi Popel
- Phone Number: +375291759336
- Email: hpopel@mail.ru
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with Reduced Cerebrovascular Reserve
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Carotid revascularization
|
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Patients with Sufficient Cerebrovascular Reserve
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Carotid revascularization
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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:
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Occurrence of symptoms within 30 postoperative days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 455
- 20251402/497 (Other Identifier: State Committee on Science and Technology)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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