Neurological Outcome With Carotid Artery Stenting (CAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT00597974
First received: January 9, 2008
Last updated: June 2, 2015
Last verified: June 2015
  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 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)


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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 9, 2008
Last Updated: June 2, 2015
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
Arterial Occlusive Diseases
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2015