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Ischemic Postconditioning in Carotid Surgery

Ischemic Postconditioning in Prevention of Brain Damage After Carotid Surgery - a Clinical Trial for Vascular Evaluation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06359756
Acronym
BRAIN-SAVE
Enrollment
40
Registered
2024-04-11
Start date
2023-09-01
Completion date
2026-01-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Diseases, Carotid Surgery, Ischemic Postconditioning, Stroke

Keywords

Ischemic Postconditioning, Carotid Surgery

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.

Interventions

PROCEDUREIschemic postconditioning in carotid surgery

After the initial declamping of the carotid artery the procedure is performed with 6 cycles of reperfusion of 30 seconds each (clamping of the internal carotid artery) which are successively followed by 6 cycles of ischemia lasting 30 seconds (clamping of the internal carotid artery). Clamping is done on the unaltered ICA, at the clamping site prior to performing CEA above the plaque termination point.

PROCEDUREEversion Carotid Endarterectomy

Standard Eversion Carotid Endarterectomy

Sponsors

Institute for Cardiovascular Diseases Dedinje
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* unilateral carotid artery stenosis \>90% * bilateral stenosis \>80% * unilateral stenosis \>80% with contralateral occlusion/subocclusion

Exclusion criteria

* urgent carotid endarterectomy * carotid restenosis * "major surgery" in the last 6 months * malignant diseases * previous brain trauma or surgery * epilepsy

Design outcomes

Primary

MeasureTime frame
Number of Participants with perioperative strokeDuring and 30 days after surgery
Number of Participants with perioperative deathDuring and 30 days after surgery

Countries

Serbia

Contacts

PRINCIPAL_INVESTIGATORNenad Ilijevski, PhD

Institute for Cardiovascular Diseases Dedinje

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026