Ischemic Postconditioning in Carotid Surgery

Stroke Clinical Trial

— BRAIN-SAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359756
• Other study ID #: BRAIN-SAVE1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Institute for Cardiovascular Diseases "Dedinje"
• Contact: Jovan Petrovic, MD
• Phone: +381113601705
• Email: jovanpetrovic1997[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Surgery
• Ischemia
• Ischemic Postconditioning
• Stroke

Intervention

Procedure:
• Ischemic 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.
• Eversion Carotid Endarterectomy
Standard Eversion Carotid Endarterectomy

Locations

Country	Name	City	State
Serbia	Institute for Cardiovascular Diseases Dedinje	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Cardiovascular Diseases "Dedinje"

Country where clinical trial is conducted

Serbia, 

References & Publications (1)

Ilijevski N, Atanasijevic I, Lozuk B, Gajin P, Matic P, Babic S, Sagic D, Unic-Stojanovic D, Tanaskovic S. Direct Ischemic Postconditioning After Carotid Endarterectomy in the Prevention of Postoperative Cerebral Ischemic Complications-Observational Case-Control Study. J Cardiovasc Pharmacol Ther. 2022 Jan-Dec;27:10742484221137489. doi: 10.1177/10742484221137489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with perioperative stroke		During and 30 days after surgery
Primary	Number of Participants with perioperative death		During and 30 days after surgery