Study of Blood Flow Changes and Microemboli During Carotid Surgery

Not Applicable

• Conditions: Carotid Endarterectomy; Percutaneous Transluminal Angioplasty; Cognitive Aspects; Diffusion Weighted MRI
• Interventions: Procedure: carotid stenting; Procedure: carotid endarterectomy

• Registration Number: NCT01343615
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-28
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-04-29
• Primary Completion: 2012-01
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• acoustic window for transcranial Doppler
• surgical criteria proposed by the NASCET and ACAS studies
• postoperative follow-up for at least six months
• patient consent

Exclusion Criteria

• carotid restenosis
• combined surgery
• emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carotid stenting	carotid stenting	-
carotid endarterectomy	carotid endarterectomy	-

Primary Outcome Measures

Name	Time	Method
Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty	6 months	The blood flow velocity of the middle cerebral artery will be measured in cm / s and the number of microemboli will be represented by the number of microemboli signals measured by transcranial Doppler ultrasound.
Number of ischemic areas detected by magnetic resonance	6 months
Neuropsychological changes	6 months	Neuropsychological alterations will be assessed through cognitive tests, which generate scores. It will be used: Mini Mental State Examination, Rey's Auditory-Verbal Learning Test, Copy and evocation of Rey's Complex Figure, Weschsler's Immediate Memory Test (direct and indirect digit span ), Lexical and Categorical Verbal Fluency, Stroop Test, Visuospatial Perception Test of Luria's Neuropsychological Investigation, Trail Making Test A e B, Boston Naming Test.

Trial Locations

Locations (1)

Hospital de Clínicas da Unicamp; 🇧🇷 Campinas, SP, Brazil