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Study of Blood Flow Changes and Microemboli During Carotid Surgery
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by University of Campinas, Brazil.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Campinas, Brazil
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01343615
First received: April 25, 2011
Last updated: April 28, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.
| Condition | Intervention |
|---|---|
| Carotid Endarterectomy Percutaneous Transluminal Angioplasty Cognitive Aspects Diffusion Weighted MRI | Procedure: carotid stenting Procedure: carotid endarterectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty |
Resource links provided by NLM:
Further study details as provided by University of Campinas, Brazil:
Primary Outcome Measures:
- Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty [ Time Frame: 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 [ Time Frame: 6 months ]
- Neuropsychological changes [ Time Frame: 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: carotid stenting |
Procedure: carotid stenting
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.
|
| Active Comparator: carotid endarterectomy |
Procedure: carotid endarterectomy
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01343615
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343615
Locations
| Brazil | |
| Hospital de Clínicas da Unicamp | Recruiting |
| Campinas, SP, Brazil, 13083887 | |
| Contact: Germano da Paz Oliveira +551997736169 germanooliveira@hotmail.com | |
| Contact: Luciana A. Moreira da Paz Oliveira +551186845502 lu21moreira@hotmail.com | |
Sponsors and Collaborators
University of Campinas, Brazil
More Information
| Responsible Party: | Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty, Unicamp |
| ClinicalTrials.gov Identifier: | NCT01343615 History of Changes |
| Other Study ID Numbers: |
MES2011 |
| Study First Received: | April 25, 2011 |
| Last Updated: | April 28, 2011 |
ClinicalTrials.gov processed this record on July 27, 2017