Cognitive Outcome After Carotid Surgery

Status Completed

Clinical Trial Summary

The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or worsening of thinking or memory. There have been many studies on this subject, some finding that certain patients gain improvement in their brain function and others might get worse. The goal of this study is to discover which patients are more likely to have improved cognitive functioning. Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and stenting (CAS) are not investigational and are an accepted treatment for your condition. In addition, subjects that choose not to undergo surgery will also be included in this study.

Clinical Trial Description

At the present time, large multi-center clinical trials support the use of carotid revascularization for symptomatic carotid stenosis and for asymptomatic carotid stenosis (greater than 60%) to prevent stroke. Guidelines supporting the use of carotid endarterectomy for asymptomatic stenosis are based largely on the Asymptomatic Carotid Atherosclerosis Study (ACAS) which reported a 47% relative risk reduction for ipsilateral stroke or death in patients randomized to surgery compared to best medical management over 5 years. These data were further substantiated by the recent publication of the Medical Research Council Asymptomatic Carotid Surgery (ACST) trial results (1); however, both trials estimated that at least 40 operative procedures were required to prevent a single disabling stroke or death in one patient after 5 years (2). These data underscore the importance of understanding the cognitive risks of carotid revascularization and developing strategies to limit factors that contribute to this risk especially in asymptomatic patients.

The purpose of this study is to better understand the effect of carotid revascularization (using either carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS)) on cognitive outcome by prospectively collecting cerebral blood flow data and cognitive testing data prior to and after carotid revascularization procedures. ;

Study Design

Related Conditions & MeSH terms

Carotid Stenosis

Clinical Trial Details

NCT number	NCT02118233
Study type	Observational
Source	Lahey Clinic
Contact
Status	Completed
Phase
Start date	April 2014
Completion date	November 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03631381` - Retrospective Study of Carotid Surgery in Dijon
Completed	`NCT05437991` - Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis	N/A
Completed	`NCT02722720` - Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral	N/A
Completed	`NCT02336958` - Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration	N/A
Completed	`NCT02630862` - Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization	N/A
Completed	`NCT00536796` - Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets	N/A
Recruiting	`NCT05566301` - Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)
Completed	`NCT03303534` - Short-Term Endogenous Hydrogen Sulfide Upregulation	N/A
Completed	`NCT01480206` - Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
Recruiting	`NCT05250349` - TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Recruiting	`NCT05845710` - Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)	N/A
Recruiting	`NCT01732523` - Predictive Value of Neovascularization Within Asymptomatic Carotis Stenosis on CEUS
Completed	`NCT01315288` - A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis	N/A
Withdrawn	`NCT00401921` - A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy	Phase 2
Recruiting	`NCT01273350` - A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)	N/A
Completed	`NCT03215550` - PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Completed	`NCT03215563` - PET-MRI Imaging in Patients With Acute Neurovascular Syndrome
Completed	`NCT04553549` - Safety and Feasibility of the Infinity Catheter for Radial Access
Completed	`NCT03596229` - Major Adverse Cardiac Events After Carotid Endarterectomy
Completed	`NCT04255316` - Modified Method of Eversion Carotid Endarterectomy in Patients With Extensive Atherosclerotic Disease of Carotid Bifurcation	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.