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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

Sponsor:

ClinicalTrials.gov Identifier:

NCT01343615

First Posted: April 28, 2011

Last Update Posted: April 29, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

University of Campinas, Brazil

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: None (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:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

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

Information from the National Library of Medicine

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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

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


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 Submitted:	April 25, 2011
First Posted:	April 28, 2011
Last Update Posted:	April 29, 2011
Last Verified:	April 2011

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