Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases; Carotid Atherosclerosis; Carotid Artery Stenosis; Cerebral Hyperperfusion Syndrome
• Intervention / Treatment: Procedure: Carotid revascularization

• Study Type: Observational
• Enrollment (Estimated): 500

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

• Belarus
  • 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: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who will undergo carotid revascularization procedures

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with reduced cerebrovascular reserve	Procedure: Carotid revascularization; Carotid revascularization
Patients with sufficient cerebrovascular reserve	Procedure: Carotid revascularization; Carotid revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): May 3, 2025
• Study Completion (Estimated): May 3, 2030

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Carotid Stenosis; Deep Learning; Cerebral Hyperperfusion Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Syndrome; Carotid Stenosis; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No