Carotid Artery DiseaseCASNCT00597974
Neurological Outcome With Carotid Artery Stenting
An observational study of Carotid Artery Disease and Carotid Artery Stenosis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease, Carotid Artery Stenosis, Stroke
- What is being tested?
- Angioplasty, Stent and Neurological and neuropsychological evaluations
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Columbia University/NY Presbyterian Hospital
Who may be able to join
- ability to speak English or Spanish
- scheduled to undergo carotid artery angioplasty and/or stent-supported angioplasty or coronary angiography
Who cannot join
- history of permanent neurological impairment
- Axis I psychiatric diagnosis or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University, Department of Anesthesiology
New York, New York, 10032
About this study
Official title: Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty
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.
Read the 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.
We will also evaluate each patient's quality of life using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention HealthRelated Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.
Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial cell component respectively, markers of cell injury will demonstrate cerebral injury. Serum levels of TNFá (Tumor Necrosis Factor Alpha) and IL8 (Interleukin 8) will be used to evaluate the presence and degree of systemic inflammatory response.
DNA genotyping will be performed either by isolating leukocytes from blood and/or by obtaining a buccal swab sample. Normally blood is sampled via the femoral arterial catheter for assessment of hematocrit, and blood gas analysis.
Patients will undergo an intraprocedural transcranial Doppler ultrasonograph (TCD). TCD monitoring probes will be placed on the patient's head with a standard head frame after sedation, one probe on each side to measure the cerebral blood flow (CBF) velocity and determine the presence of emboli in the middle cerebral artery (MCA) on either side of the brain (Spencer Technologies, Seattle, WA). We hypothesize that there may be a relationship between emboli and subtle cognitive decline as ascertained by the battery of neuropsychometric exams. An electroencephalogram (EEG) will be applied to monitor for significant hemispheric cerebral ischemia which may occur when the balloon is inflated and occludes the artery. We routinely use EEG monitoring during carotid endarterectomy and its use exposes the patient to no risk.
- Being tested
- Angioplasty, Stent, Neurological and neuropsychological evaluations, Angiography
- Keywords
- carotid artery stenosis, Neuropsychological tests, Stroke, Transient ischemia, Stenting
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastyProcedure or surgery
(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty
StentDevice
(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)
Neurological and neuropsychological evaluationsOther
Clinical examinations consisting of a neurological and neuropsychological evaluation
AngiographyProcedure or surgery
(non-experimental) Coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Angioplasty; Device: Stent; Other: Neurological and neuropsychological evaluations; Procedure: Angiography | |
| Patients having angiography (control) | Patients undergoing coronary angiography for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations Receives: Procedure: Angioplasty; Device: Stent; Other: Neurological and neuropsychological evaluations; Procedure: Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychometric Changes
Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 day.
Measured: Baseline to 1 day post-op
Secondary outcomes (1)
Neuropsychometric Changes
Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 month.
Measured: Baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startSep 2003
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric J. Heyer, MD, PhD, Columbia University
- Investigators
- Eric J Heyer, M.D., Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597974
- Sponsor's protocol ID
- AAAA2389
- Acronym
- CAS
- Status last verified
- Jun 2015
- First submitted
- 9 Jan 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001 Jan 30;103(4):532-7. doi: 10.1161/01.cir.103.4.532.
PubMed 11157718Theron JG, Payelle GG, Coskun O, Huet HF, Guimaraens L. Carotid artery stenosis: treatment with protected balloon angioplasty and stent placement. Radiology. 1996 Dec;201(3):627-36. doi: 10.1148/radiology.201.3.8939208.
PubMed 8939208Diethrich EB, Ndiaye M, Reid DB. Stenting in the carotid artery: initial experience in 110 patients. J Endovasc Surg. 1996 Feb;3(1):42-62. doi: 10.1583/1074-6218(1996)0032.0.CO;2.
PubMed 8798126Wholey MH, Wholey MH, Jarmolowski CR, Eles G, Levy D, Buecthel J. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997 Nov;4(4):326-38. doi: 10.1177/152660289700400402.
PubMed 9418194Henry M, Amor M, Klonaris C, Henry I, Masson I, Chati Z, Leborgne E, Hugel M. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000;27(2):150-8.
PubMed 10928503Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. doi: 10.1001/archneur.59.2.217.
PubMed 11843692Meyers, Philip M, Lavine, Sean D, Higashida, Randall T, Endovascular Revascularization of Carotid Artery Disease in Controversies in neurological Surgery: Neurovascular Diseases, In Press 2003.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty
- ClinicalTrials.gov ID
- NCT00597974
- Acronym / sponsor ID
- CAS / AAAA2389
- Keywords
- carotid artery stenosis, Neuropsychological tests, Stroke, Transient ischemia, Stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
We will also evaluate each patient's quality of life using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention HealthRelated Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.
Serum levels of neuron specific enolase (NSE) and protein S100B, a neuronal enzyme and glial cell component respectively, markers of cell injury will demonstrate cerebral injury. Serum levels of TNFá (Tumor Necrosis Factor Alpha) and IL8 (Interleukin 8) will be used to evaluate the presence and degree of systemic inflammatory response.
DNA genotyping will be performed either by isolating leukocytes from blood and/or by obtaining a buccal swab sample. Normally blood is sampled via the femoral arterial catheter for assessment of hematocrit, and blood gas analysis.
Patients will undergo an intraprocedural transcranial Doppler ultrasonograph (TCD). TCD monitoring probes will be placed on the patient's head with a standard head frame after sedation, one probe on each side to measure the cerebral blood flow (CBF) velocity and determine the presence of emboli in the middle cerebral artery (MCA) on either side of the brain (Spencer Technologies, Seattle, WA). We hypothesize that there may be a relationship between emboli and subtle cognitive decline as ascertained by the battery of neuropsychometric exams. An electroencephalogram (EEG) will be applied to monitor for significant hemispheric cerebral ischemia which may occur when the balloon is inflated and occludes the artery. We routinely use EEG monitoring during carotid endarterectomy and its use exposes the patient to no risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having angioplasty (case) | – | Procedure: Angioplasty, Device: Stent, Other: Neurological and neuropsychological evaluations, Procedure: AngiographyPatients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations |
| Patients having angiography (control) | – | Procedure: Angioplasty, Device: Stent, Other: Neurological and neuropsychological evaluations, Procedure: AngiographyPatients undergoing coronary angiography for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Columbia University/NY Presbyterian Hospital
Key inclusion criteria (2 listed)
- ability to speak English or Spanish
- scheduled to undergo carotid artery angioplasty and/or stent-supported angioplasty or coronary angiography
Key exclusion criteria (2 listed)
- history of permanent neurological impairment
- Axis I psychiatric diagnosis or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty | Procedure or surgery | Patients having angiography (control), Patients having angioplasty (case) |
| 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) | Device | Patients having angiography (control), Patients having angioplasty (case) |
| Neurological and neuropsychological evaluationsClinical examinations consisting of a neurological and neuropsychological evaluation | Other | Patients having angiography (control), Patients having angioplasty (case) |
| Angiography(non-experimental) Coronary angiography | Procedure or surgery | Patients having angiography (control), Patients having angioplasty (case) |
Primary outcome
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.
1 secondary outcome
Neuropsychometric Changes
Time frame: Baseline to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 11157718Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001 Jan 30;103(4):532-7. doi: 10.1161/01.cir.103.4.532.
- Background: PubMed 8939208Theron JG, Payelle GG, Coskun O, Huet HF, Guimaraens L. Carotid artery stenosis: treatment with protected balloon angioplasty and stent placement. Radiology. 1996 Dec;201(3):627-36. doi: 10.1148/radiology.201.3.8939208.
- Background: PubMed 8798126Diethrich EB, Ndiaye M, Reid DB. Stenting in the carotid artery: initial experience in 110 patients. J Endovasc Surg. 1996 Feb;3(1):42-62. doi: 10.1583/1074-6218(1996)0032.0.CO;2.
- Background: PubMed 9418194Wholey MH, Wholey MH, Jarmolowski CR, Eles G, Levy D, Buecthel J. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997 Nov;4(4):326-38. doi: 10.1177/152660289700400402.
- Background: PubMed 10928503Henry M, Amor M, Klonaris C, Henry I, Masson I, Chati Z, Leborgne E, Hugel M. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000;27(2):150-8.
- Background: PubMed 11843692Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. doi: 10.1001/archneur.59.2.217.
- BackgroundMeyers, Philip M, Lavine, Sean D, Higashida, Randall T, Endovascular Revascularization of Carotid Artery Disease in Controversies in neurological Surgery: Neurovascular Diseases, In Press 2003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Heyer, M.D., Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease and Carotid Artery Stenosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychometric Changes (time frame: Baseline to 1 day post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597974, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.