Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

Carotid Artery Diseases Clinical Trial

Official title:

Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800821
• Other study ID #: 455
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: May 3, 2030

Study information

• Verified date: March 2024
• Source: State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
• Contact: Ivan Maiseyenka
• Phone: +375333288850
• Email: i_a_moiseenko[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 3, 2030
• Est. primary completion date: May 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Atherosclerosis
• Carotid Stenosis
• Cerebral Hyperperfusion Syndrome
• Syndrome

Intervention

Procedure:
• Carotid revascularization
Carotid revascularization

Locations

Country	Name	City	State
Belarus	State Institution "Republican Scientific and Practical Center "Cardiology"	Minsk

Sponsors (1)

Lead Sponsor	Collaborator
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Country where clinical trial is conducted

Belarus, 

Outcome

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