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Study of Blood Flow Changes and Microemboli During Carotid Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Campinas, Brazil.
Recruitment status was  Recruiting
Sponsor:
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
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Neuropsychological changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Brazil: National Agency of Health

ClinicalTrials.gov processed this record on November 20, 2014