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Neurological Outcome With Carotid Artery Stenting (CAS)

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.
 
ClinicalTrials.gov Identifier: NCT00597974
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University

Brief 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.

Condition or disease Intervention/treatment
Carotid Artery Disease Carotid Artery Stenosis Stroke Transient Ischemic Attack Procedure: Angioplasty Device: Stent Other: Neurological and neuropsychological evaluations Procedure: Angiography

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Study Type : Observational
Actual Enrollment : 108 participants
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
Study Start Date : September 2003
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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United States, New York
Columbia University, Department of Anesthesiology
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Eric J Heyer, M.D., Ph.D. Columbia University
Publications:
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Responsible Party: Eric J. Heyer, MD, PhD, Professor of Clinical Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT00597974    
Other Study ID Numbers: AAAA2389
First Posted: January 18, 2008    Key Record Dates
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:
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Ischemic Attack, Transient
Carotid Artery Diseases
Carotid Stenosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Arterial Occlusive Diseases