Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study

Stroke Clinical Trial

Official title: Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study

Status Completed

Clinical Trial Summary

Aim of the study is to determine whether endovascular systemic cooling to a target temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA), is feasible and safe

Clinical Trial Description

The study is based on the hypothesis that performing CEA during hypothermia substantially reduces the risk due to a potential, temporary hypoperfusion, associated with the surgical procedure.

The rationale behind the study is based on the assumption that Carotid EndArterectomy (CEA), by removing local causes of downstream altered circulation, improves cerebral hemodynamics and provides an effective prevention of stroke and TIA. The intervention itself, however, causes immediate risk of stroke or death, and it is also an issue whether the temporary reduction of blood flow associated with clamping of the artery, during the surgical intervention, may trigger long-lasting brain tissue dysfunction.

Mild hypothermia (34-35 °C) is probably the most effective approach to protect the brain from ischemic insults. Most of the supportive data were obtained in animal models of ischemia. Several phase II trials have shown safety and feasibility of cooling subjects with stroke, in the hours following onset of symptoms. Early interventions show the highest benefit.

Eligible patients will initiate cooling 60-90 min before CEA with endovascular cooling (Zoll system) to the target 34-35°C (assessed by bladder thermometer). The Zoll IVTM system is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, an ICY catheter (either IC-3585 AE or IC-3585 CO or IC-3893 AE or IC-3893 CO), a catheter convenience kit for catheter insertion (CO models only), thermal probes and cables. All the devise component have CE mark. The Low temperature will be maintained during the CEA procedure, followed by gradual, passive, controlled rewarming (0.4 °C/h). Type of anaesthesia will be decided according to good clinical practice. The cooling procedure will be, therefore, carried out during the anaesthesia procedure required by the surgical intervention. There is a chance that the duration of the anaesthesia will be longer that required, but all the efforts will be undertaken to keep the anaesthesia time as short as if there were no cooling

Clinical and instrumental evaluations will be carried out before and post intervention. Each evaluation will consist of physical examination, neuropsychological evaluation (MoCA test), blood tests and brain MRI or TC.

Safety is evaluated on the basis of severe adverse event ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Artery Plaque
• Carotid Artery Stenosis
• Carotid Stenosis
• Cerebrovascular Accident
• Hypothermia
• Stroke

• NCT number: NCT02629653
• Study type: Interventional
• Source: S. Andrea Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Completion date: December 2015