Carotid Artery StenosisNCT04759859
Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy
An observational study of Carotid Artery Stenosis, run by CAMC Health System at 1 site in United States.
Trial summary
The study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Carotid Artery Stenosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2013to Jan 2020
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients undergoing elective carotid endarterectomy and 30 patients undergoing other peripheral vascular surgical procedures
Who may be able to join
- Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures.
- Ages 40-90
Who cannot join
- History of Substance Use:
- History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.
- Conditions that affect brain MRI/contraindications for MRI:
- Diagnosis of HIV. History of any traumatic brain injury. History or current diagnosis with any form of brain tumor. Current normal pressure hydrocephalus. Patients with any implanted metallic medical device, or non-removable metallic material in their body
- Conditions that affect neuropsychological assessment:
- Diagnosis with Attention Deficit/Hyperactivity Disorder. Current major depressive episode. Current manic episode. Current psychotic episode. Diagnosis with any developmental disorder. Diagnosis with any form of dementia (MMSE<24). A score higher than 3 on the Modified Rankin Scale indicating a major stroke.
- General Contraindications:
- Diagnosis with or history of any medical condition that, based on reasonable clinical judgment, would clinically contraindicate the patient undergoing any of the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charleston Area Medical Center Vascular Center of Excellence
Charleston, West Virginia, 25304
About this study
Official title: Relationship Between Neuropsychological Functioning and Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy
The study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures.
Read the detailed description
Carotid endarterectomy (CEA) is a vascular surgical procedure that is aimed at reducing accumulated cholesterol and fats in carotid arteries. While some research indicates that CEA is associated with improvements in neuropsychological functioning, other studies have identified deficits in neuropsychological functioning following CEA. The factors associated with these different outcomes are unclear. Identification of the factors that mediate post-CEA neuropsychological functioning outcomes may allow for the development of interventions that would improve such outcomes. Recent research has identified a relationship between post-CEA neuropsychological deficits, and cerebral blood flow in certain areas of the brain, with some indication that brain cell loss following CEA may be a key factor. The proposed study will explore changes in cerebral blood flow through the use of diffusion-weighted magnetic resonance images (DW-MRI) to investigate the relationship between neuropsychological functioning and brain perfusion in 70 CEA patients and to compare neuropsychological functioning of the CEA patients to a control group of 30 patients undergoing other peripheral vascular surgical procedures. Patients' neuropsychological functioning will be assessed pre, post and six months after the CEA or peripheral vascular surgery. Additionally DW-MRI will be assessed pre and post surgery for the patients undergoing CEA.
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid Endarterectomy, Neurocognitive Functioning, Cerebral Perfusion
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Endarterectomy (CEA) | 70 participants undergoing CEA | |
| Other Peripheral Vascular Surgery | 30 participants undergoing other peripheral vascular surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
A battery of eight neuropsychological tests
Measured: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
Secondary outcomes (1)
Diffusion Weighted Magnetic Resonance Imaging
Measured: 7 days before surgery, 1-7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start22 Jan 2013 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: logistical issues with coordinating the clinical and testing areas
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AbuRahma, CAMC Health System
- Investigators
- Ali AbuRahma, MD, Principal investigator, Charleston Area Medical Center Vascular Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759859
- Sponsor's protocol ID
- 1997246
- Status last verified
- Jan 2014
- First submitted
- 27 Nov 2013
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Neuropsychological Functioning and Cerebral Perfusion in Patients Undergoing Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT04759859
- Acronym / sponsor ID
- 1997246
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid Endarterectomy, Neurocognitive Functioning, Cerebral Perfusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: logistical issues with coordinating the clinical and testing areas
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 22 Jan 2013 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Feb 2021 (actual)
- 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 study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures.
Detailed description
Carotid endarterectomy (CEA) is a vascular surgical procedure that is aimed at reducing accumulated cholesterol and fats in carotid arteries. While some research indicates that CEA is associated with improvements in neuropsychological functioning, other studies have identified deficits in neuropsychological functioning following CEA. The factors associated with these different outcomes are unclear. Identification of the factors that mediate post-CEA neuropsychological functioning outcomes may allow for the development of interventions that would improve such outcomes. Recent research has identified a relationship between post-CEA neuropsychological deficits, and cerebral blood flow in certain areas of the brain, with some indication that brain cell loss following CEA may be a key factor. The proposed study will explore changes in cerebral blood flow through the use of diffusion-weighted magnetic resonance images (DW-MRI) to investigate the relationship between neuropsychological functioning and brain perfusion in 70 CEA patients and to compare neuropsychological functioning of the CEA patients to a control group of 30 patients undergoing other peripheral vascular surgical procedures. Patients' neuropsychological functioning will be assessed pre, post and six months after the CEA or peripheral vascular surgery. Additionally DW-MRI will be assessed pre and post surgery for the patients undergoing CEA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid Endarterectomy (CEA) | – | –70 participants undergoing CEA |
| Other Peripheral Vascular Surgery | – | –30 participants undergoing other peripheral vascular surgical procedures |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients undergoing elective carotid endarterectomy and 30 patients undergoing other peripheral vascular surgical procedures
Key inclusion criteria (2 listed)
- Patients undergoing elective carotid endarterectomy or other peripheral vascular surgical procedures.
- Ages 40-90
Key exclusion criteria (8 listed)
- History of Substance Use:
- History of cocaine use within the past 12 months. Tetrahydrocannabinol use within the past 12 months.
- Conditions that affect brain MRI/contraindications for MRI:
- Diagnosis of HIV. History of any traumatic brain injury. History or current diagnosis with any form of brain tumor. Current normal pressure hydrocephalus. Patients with any implanted metallic medical device, or non-removable metallic material in their body
- Conditions that affect neuropsychological assessment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A battery of eight neuropsychological tests
Time frame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery
1 secondary outcome
Diffusion Weighted Magnetic Resonance Imaging
Time frame: 7 days before surgery, 1-7 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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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.
Ali AbuRahma, MD principal investigator
Charleston Area Medical Center Vascular Center of Excellence
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 Stenosis, run by CAMC Health System 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 8 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: withdrawn, as of the sponsor's last update on 18 Feb 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
A battery of eight neuropsychological tests (time frame: 7 days before surgery, 1-7 days after surgery and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.