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Neurological Outcome With Carotid Artery Stenting (CAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597974
First Posted: January 18, 2008
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
  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 Intervention
Carotid Artery Disease Carotid Artery Stenosis Stroke Transient Ischemic Attack Procedure: Angioplasty Device: Stent Other: Neurological and neuropsychological evaluations Procedure: Angiography

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:


Further study details as provided by Eric J. Heyer, MD, PhD, Columbia University:

Primary Outcome Measures:
  • Neuropsychometric Changes [ Time Frame: Baseline to 1 day post-op ]
    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 ]
    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)

Enrollment: 108
Study Start Date: September 2003
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients having angioplasty (case)
Patients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations
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
Patients having angiography (control)
Patients undergoing coronary angiography for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Columbia University/NY Presbyterian Hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597974


Locations
United States, New York
Columbia University, Department of Anesthesiology
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:
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
First Submitted: January 9, 2008
First Posted: January 18, 2008
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Eric J. Heyer, MD, PhD, Columbia University:
carotid artery stenosis
Neuropsychological tests
Stroke
Transient ischemia
Stenting

Additional relevant MeSH terms:
Ischemic Attack, Transient
Carotid Artery Diseases
Carotid Stenosis
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases