Neurological Outcome With Carotid Artery Stenting (CAS)

This study is currently recruiting participants.

Verified November 2012 by Columbia University

Sponsor:

Information provided by (Responsible Party):

Eric J. Heyer, MD, PhD, Columbia University

ClinicalTrials.gov Identifier:

NCT00597974

First received: January 9, 2008

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition
Carotid Artery Disease Carotid Artery Stenosis Stroke Transient Ischemic Attack

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Carotid Artery Disease Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Neuropsychometric Changes [ Time Frame: Baseline to 1 day post-op ] [ Designated as safety issue: No ]
Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 day.

Secondary Outcome Measures:

Neuropsychometric Changes [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]
Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 month.

Biospecimen Retention: Samples With DNA

plasma serum DNA (obtained via buccal samples using a buccal cell collection swab)

Estimated Enrollment:	200
Study Start Date:	September 2003
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Columbia University/NY Presbyterian Hospital

Criteria

Inclusion Criteria:

ability to speak English

Exclusion Criteria:

history of permanent neurological impairment
Axis I psychiatric diagnosis or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597974

Contacts

Contact: Joanna L Mergeche, BA	212-305-8949	jm3596@columbia.edu
Contact: Eric Heyer, M.D., Ph.D.	212-305-9072	ejh3@columbia.edu

Locations

United States, New York
Columbia University, Department of Anesthesiology	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Eric J Heyer, M.D., Ph.D.

Columbia University

More Information

Publications:

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.

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.

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.

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.

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.

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.

Responsible Party:	Eric J. Heyer, MD, PhD, Professor of Clinical Anesthesiology, Columbia University
ClinicalTrials.gov Identifier:	NCT00597974 History of Changes
Other Study ID Numbers:	AAAA2389
Study First Received:	January 9, 2008
Last Updated:	November 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

carotid artery stenosis
Neuropsychological tests
Stroke
Transient ischemia
Stenting

Additional relevant MeSH terms:

Carotid Artery Diseases
Carotid Stenosis
Ischemic Attack, Transient
Constriction, Pathologic
Stroke
Cerebrovascular Disorders
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Brain Ischemia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013

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