Back to resultsStudy of Blood Flow Changes and Microemboli During Carotid Surgery
Primary Purpose
Carotid Endarterectomy, Percutaneous Transluminal Angioplasty, Cognitive Aspects
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
carotid stenting
carotid endarterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Endarterectomy
Eligibility Criteria
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
Sites / Locations
- Hospital de Clínicas da UnicampRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
carotid stenting
carotid endarterectomy
Arm Description
Outcomes
Primary Outcome Measures
Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty
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
Neuropsychological changes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01343615
First Posted
April 25, 2011
Last Updated
April 28, 2011
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT01343615
Brief Title
Study of Blood Flow Changes and Microemboli During Carotid Surgery
Official Title
Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Endarterectomy, Percutaneous Transluminal Angioplasty, Cognitive Aspects, Diffusion Weighted MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
carotid stenting
Arm Type
Active Comparator
Arm Title
carotid endarterectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
carotid stenting
Intervention Description
A group of patients will be operated by endovascular technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects.
Intervention Type
Procedure
Intervention Name(s)
carotid endarterectomy
Intervention Description
A group of patients will be operated by open technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects
Primary Outcome Measure Information:
Title
Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty
Description
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.
Time Frame
6 months
Title
Number of ischemic areas detected by magnetic resonance
Time Frame
6 months
Title
Neuropsychological changes
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital de Clínicas da Unicamp
City
Campinas
State/Province
SP
ZIP/Postal Code
13083887
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germano da Paz Oliveira
Phone
+551997736169
Email
germanooliveira@hotmail.com
First Name & Middle Initial & Last Name & Degree
Luciana A. Moreira da Paz Oliveira
Phone
+551186845502
Email
lu21moreira@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Study of Blood Flow Changes and Microemboli During Carotid Surgery
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