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Study of Blood Flow Changes and Microemboli During Carotid Surgery

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ClinicalTrials.gov Identifier: NCT01343615
Recruitment Status : Unknown
Verified April 2011 by University of Campinas, Brazil.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
University of Campinas, Brazil

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.

Condition or disease Intervention/treatment Phase
Carotid Endarterectomy Percutaneous Transluminal Angioplasty Cognitive Aspects Diffusion Weighted MRI Procedure: carotid stenting Procedure: carotid endarterectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty
Study Start Date : September 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Number of ischemic areas detected by magnetic resonance [ Time Frame: 6 months ]
  3. 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.


Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011