Study of Blood Flow Changes and Microemboli During Carotid Surgery
|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
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343615
|Hospital de Clínicas da Unicamp||Recruiting|
|Campinas, SP, Brazil, 13083887|
|Contact: Germano da Paz Oliveira +551997736169 email@example.com|
|Contact: Luciana A. Moreira da Paz Oliveira +551186845502 firstname.lastname@example.org|