Study of Blood Flow Changes and Microemboli During Carotid Surgery

Carotid Endarterectomy Clinical Trial

Official title:

Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01343615
• Other study ID #: MES2011
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2011
• Last updated: April 28, 2011
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Agency of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Cognitive Aspects
• Diffusion Weighted MRI
• Percutaneous Transluminal Angioplasty

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas da Unicamp	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty	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.	6 months	No
Primary	Number of ischemic areas detected by magnetic resonance		6 months	No
Primary	Neuropsychological changes	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.	6 months	No