Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800821
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-03-13
Brief Title:
Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
Sponsor:
State Institution Republican Scientific and Practical Center Cardiology Belarus
Organization:
State Institution Republican Scientific and Practical Center Cardiology Belarus
Study Overview
Official Title:
Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None