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Procedure
Carotid Artery Stenting for Cognitive Impairment
N/A
Recruiting
Led By Alexander A Khalessi, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ultrasound evidence of carotid stenosis; in which the patient has either 50% or greater symptomatic carotid stenosis or 70% or greater asymptomatic carotid stenosis.
Patients must be over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial is designed to see if there is a relationship between carotid disease and decreased cognitive function. They will do this by testing people's cognitive function before and after they have a stent put in to help with blood flow.
Who is the study for?
This trial is for adults over 18 with carotid artery disease, evidenced by significant narrowing of the carotid arteries. It's not suitable for those under 18, lacking capacity to consent, needing emergency stenting, incompatible with MRI scans or intolerant to normal blood pressure levels.Check my eligibility
What is being tested?
The study aims to understand how narrowed carotid arteries affect brain function. Participants will undergo neurocognitive tests and have their blood checked for inflammation markers before and after getting a procedure called Carotid Artery Stenting.See study design
What are the potential side effects?
Potential side effects may include discomfort from cognitive assessments and risks associated with Carotid Artery Stenting such as stroke, bruising or bleeding at the insertion site, and reactions to contrast dye used in imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ultrasound shows I have significant narrowing in my carotid artery.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurocognition
Secondary outcome measures
CRP
IFN-γ
IL-1β
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment3 Interventions
Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points after invention (1 month and 2 months). The two postoperative time points will serve as the intervention group.
Group II: Control GroupActive Control2 Interventions
Patients, as outlined by NASCET criteria, will have between 50 symptomatic stenosis or 70% asymptomatic stenosis of the carotid artery. Patients, undergoing carotid artery stenting for carotid stenosis, will undergo cognitive testing at 2 time points before intervention (1 months, and 2 months). The two preoperative time points will serve as the control group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carotid Artery Stenting
2013
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,405 Total Patients Enrolled
David R Santiago-Dieppa, MDStudy DirectorUC San Diego
Alexander A Khalessi, MDPrincipal InvestigatorUC San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ultrasound shows I have significant narrowing in my carotid artery.I need an urgent procedure for my carotid artery due to worsening symptoms.I am younger than 18 years old.I am over 18 years old.I understand the risks and benefits of this study and can consent for myself.I need a procedure to open my neck artery for reasons other than long-term narrowing.You cannot have an MRI scan done.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of participants for this clinical research endeavor?
"Correct. The medical trial is documented on clinicaltrials.gov, with the first posting occurring on July 15th 2021, and an update being applied February 8th 2021. Presently, 20 participants are sought at a single location of recruitment."
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