Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359756
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-06
Brief Title:
Ischemic Postconditioning in Carotid Surgery
Sponsor:
Institute for Cardiovascular Diseases Dedinje
Organization:
Institute for Cardiovascular Diseases Dedinje
Study Overview
Official Title:
Ischemic Postconditioning in Prevention of Brain Damage After Carotid Surgery - a Clinical Trial for Vascular Evaluation
Status:
RECRUITING
Status Verified Date:
2024-08
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:
BRAIN-SAVE
Brief Summary:
Analyzing changes in cerebral oximetry transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery IPCT
Detailed Description:
Eversion carotid endarterectomy eCEA has proven effective in preventing ischemic brain damage resulting from atherosclerotic disease in the extracranial segment of the carotid arteries Over time advancements in surgical techniques have led to a reduction in the incidence of perioperative stroke To better understand the concept of stroke complications following CEA a clear distinction between intraprocedural and postprocedural strokes is necessary Periprocedural strokes are attributed to hypoperfusion or embolization from the site of endarterectomy while defined causes of postprocedural strokes include local carotid artery thrombosis or cerebral hyperperfusion syndrome CHS
CHS occurring in 1-3 of cases is a potentially catastrophic event following eCEA primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics Patients with significant carotid stenosis are particularly vulnerable to CHS due to prolonged cerebral hypoperfusion where collateral circulation serves as a protective mechanism Another pathway leading to CHS involves increased free radical concentrations damaging the blood-brain barrier Identified risk factors for CHS development include advanced age prior ischemic cerebrovascular events and contralateral stenosis 70
Various methods for predicting CHS development and collateral circulation insufficiency include cerebral oximetry transcranial Doppler sonography perfusion computed tomography and quantitative magnetic resonance imaging Cerebral oximetry with real-time detection of cerebral oxygenated hemoglobin saturation exhibits promising sensitivity and specificity in predicting CHS occurrence
Analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into CHS pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery IPCT in high-risk patients IPCT shown to have a protective effect in animal models recently demonstrated encouraging results in human trials
Utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial Doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after IPCT validating its protective effect and safety in high-risk CHS scenarios
CHS occurring in 1-3 of cases is a potentially catastrophic event following eCEA primarily resulting from impaired autoregulation mechanisms and post-revascularization changes in cerebral hemodynamics Patients with significant carotid stenosis are particularly vulnerable to CHS due to prolonged cerebral hypoperfusion where collateral circulation serves as a protective mechanism Another pathway leading to CHS involves increased free radical concentrations damaging the blood-brain barrier Identified risk factors for CHS development include advanced age prior ischemic cerebrovascular events and contralateral stenosis 70
Various methods for predicting CHS development and collateral circulation insufficiency include cerebral oximetry transcranial Doppler sonography perfusion computed tomography and quantitative magnetic resonance imaging Cerebral oximetry with real-time detection of cerebral oxygenated hemoglobin saturation exhibits promising sensitivity and specificity in predicting CHS occurrence
Analyzing changes in biomarkers of neuronal ischemic injury and blood-brain barrier integrity offers insight into CHS pathophysiology and indirectly assesses the safety and efficacy of ischemic postconditioning of the carotid artery IPCT in high-risk patients IPCT shown to have a protective effect in animal models recently demonstrated encouraging results in human trials
Utilizing intraoperative neuromonitoring with cerebral oximetry and transcranial Doppler enables real-time monitoring of cerebral oxygenated hemoglobin saturation and flow characteristics during and after IPCT validating its protective effect and safety in high-risk CHS scenarios
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