Study of Blood Flow Changes and Microemboli During Carotid Surgery
Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedApril 29, 2011
April 1, 2011
1.3 years
April 25, 2011
April 28, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
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.
6 months
Number of ischemic areas detected by magnetic resonance
6 months
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.
6 months
Study Arms (2)
carotid stenting
ACTIVE COMPARATORcarotid endarterectomy
ACTIVE COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- acoustic window for transcranial Doppler
- surgical criteria proposed by the NASCET and ACAS studies
- postoperative follow-up for at least six months
- patient consent
You may not qualify if:
- carotid restenosis
- combined surgery
- emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas da Unicamp
Campinas, São Paulo, 13083887, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2011
First Posted
April 28, 2011
Study Start
September 1, 2010
Primary Completion
January 1, 2012
Study Completion
July 1, 2012
Last Updated
April 29, 2011
Record last verified: 2011-04