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

History of Changes

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:

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 ] [ 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 February 27, 2015

To Top