Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Neuropsychometric Changes
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Neuropsychometric Changes(Baseline to 1 month)
Investigators
Eric J. Heyer, MD, PhD
Professor of Clinical Anesthesiology
Columbia University
