Neurological Outcome With Carotid Artery Stenting

Stroke Clinical Trial

— CAS  

Official title:

Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597974
• Other study ID #: AAAA2389
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: June 2, 2015
• Start date: September 2003
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine how well patients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will perform on a battery of tests to assess brain function before and after the procedure. This study will serve as a pilot project: (a) to determine incidence of neurologic/neuropsychometric change in patients undergoing carotid artery angioplasty and/or stent-supported angioplasty, and (b) to ascertain the time it takes for these changes to resolve.

Description:

We hypothesize that the incidence of subtle neuropsychometric injury will be significantly greater than the incidence of stroke comparable to what we found in patients having carotid endarterectomy. Patients will be evaluated prospectively to determine the incidence of neurological morbidity based on both the neurologic/neuropsychometric examinations

The results of this study will serve to (a) determine incidence of neurologic/neuropsychometric morbidity for patients undergoing carotid artery angioplasty and/or stenting at ColumbiaPresbyterian Medical Center, (b) ascertain the time course of these changes, (c) identify intraprocedural markers for these changes, and (d) design protocols to evaluate the efficacy of therapeutic interventions.

Cerebral injury will be determined three ways.

First, all patients will be evaluated using a battery of neuropsychometric tests before and after the procedure. Persons presenting to the hospital on the day of the procedure, referred to hereafter as "Same Day", will be evaluated on the day of the procedure, one day after and at the 1 month follow up.

Preoperative neurological and neuropsychological evaluation will be performed. The neuropsychometric tests are designed to demonstrate general neuropsychological pathology. These tests can be divided into four types: (1) an evaluation of language, (2) an evaluation of speed of mental processing, (3) an evaluation of ability to learn using a list of words, and (4) an evaluation of visual perception requiring a patient to copy a complex figure. Before the battery is administered we will assess each patient's level of pain while sitting and standing using a 10 point Visual Analog Scale and then gauge their mood with a series called the Wong/Baker Faces Rating scale.

We will also evaluate each patient's quality of life using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention HealthRelated Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.

Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial cell component respectively, markers of cell injury will demonstrate cerebral injury. Serum levels of TNFá (Tumor Necrosis Factor Alpha) and IL8 (Interleukin 8) will be used to evaluate the presence and degree of systemic inflammatory response.

DNA genotyping will be performed either by isolating leukocytes from blood and/or by obtaining a buccal swab sample. Normally blood is sampled via the femoral arterial catheter for assessment of hematocrit, and blood gas analysis.

Patients will undergo an intraprocedural transcranial Doppler ultrasonograph (TCD). TCD monitoring probes will be placed on the patient's head with a standard head frame after sedation, one probe on each side to measure the cerebral blood flow (CBF) velocity and determine the presence of emboli in the middle cerebral artery (MCA) on either side of the brain (Spencer Technologies, Seattle, WA). We hypothesize that there may be a relationship between emboli and subtle cognitive decline as ascertained by the battery of neuropsychometric exams. An electroencephalogram (EEG) will be applied to monitor for significant hemispheric cerebral ischemia which may occur when the balloon is inflated and occludes the artery. We routinely use EEG monitoring during carotid endarterectomy and its use exposes the patient to no risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ability to speak English or Spanish

• scheduled to undergo carotid artery angioplasty and/or stent-supported angioplasty or coronary angiography

Exclusion Criteria:

• history of permanent neurological impairment

• Axis I psychiatric diagnosis or drug abuse

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Artery Stenosis
• Carotid Stenosis
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Procedure:
• Angioplasty
(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty

Device:
• Stent
(non-experimental) Precise™ Nitinol Self-Expanding Stent (Cordis Endovascular, Johnson & Johnson), S.M.A.R.T.® Control™ Stent (Cordis Endovascular, Johnson & Johnson), Wallstent® (Boston Scientific Medi-Tech)

Other:
• Neurological and neuropsychological evaluations
Clinical examinations consisting of a neurological and neuropsychological evaluation

Procedure:
• Angiography
(non-experimental) Coronary angiography

Locations

Country	Name	City	State
United States	Columbia University, Department of Anesthesiology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Diethrich EB, Ndiaye M, Reid DB. Stenting in the carotid artery: initial experience in 110 patients. J Endovasc Surg. 1996 Feb;3(1):42-62. — View Citation

Henry M, Amor M, Klonaris C, Henry I, Masson I, Chati Z, Leborgne E, Hugel M. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000;27(2):150-8. — View Citation

Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. — View Citation

Meyers, Philip M, Lavine, Sean D, Higashida, Randall T, Endovascular Revascularization of Carotid Artery Disease in Controversies in neurological Surgery: Neurovascular Diseases, In Press 2003.

Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001 Jan 30;103(4):532-7. — View Citation

Theron JG, Payelle GG, Coskun O, Huet HF, Guimaraens L. Carotid artery stenosis: treatment with protected balloon angioplasty and stent placement. Radiology. 1996 Dec;201(3):627-36. — View Citation

Wholey MH, Wholey MH, Jarmolowski CR, Eles G, Levy D, Buecthel J. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997 Nov;4(4):326-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychometric Changes	Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 day.	Baseline to 1 day post-op	No
Secondary	Neuropsychometric Changes	Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 month.	Baseline to 1 month	No