Skip to main content
Clinical Trials/NCT00597974
NCT00597974CompletedNot Applicable

Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty

Columbia University1 site in 1 country108 target enrollmentStarted: September 2003Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eric J. Heyer, MD, PhD

Professor of Clinical Anesthesiology

Columbia University

Study Sites (1)

Loading locations...

Similar Trials