Extracranial carotid disease revascularization.
Donald E Cutlip, Duane S Pinto
https://pubmed.ncbi.nlm.nih.gov/23184283Actively Recruiting
Age: 18Years - 85Years
All Genders
ID05539781
Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization
Led by Beijing Friendship Hospital · Updated on 2022-09-14
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with significant narrowing of the carotid arteries, a major cause of ischemic stroke. The trial aims to compare two treatment methods: carotid artery stenting (CAS) and carotid endarterectomy (CEA), focusing on their long-term effects on artery function and brain health, including cognitive changes after treatment. The study also explores how changes in blood flow and artery wall stress relate to risks of complications and artery narrowing after treatment. Participants will undergo carotid artery revascularization through either CAS or CEA. The study involves detailed imaging with multimodal MRI before treatment and at follow-ups, along with cognitive tests conducted before treatment and repeatedly for up to four years. Researchers will analyze blood flow patterns, arterial wall stress indices, and brain imaging results to understand how these factors relate to post-treatment outcomes. During the study, participants will complete cognitive assessments at baseline, 44 days, and annually up to four years. MRI scans will be performed within two weeks of enrollment and prior to intervention, with standardized protocols to ensure consistent imaging quality. Primary outcomes measured after one year include changes in cognitive scores, carotid artery narrowing, and blood flow dynamics. Secondary outcomes include detection of silent brain infarcts, white matter changes, cardiovascular events, and mortality rates. The study is observational and aims to find new predictors of recovery and complications after carotid artery procedures.
CONDITIONS
Brief Title
Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Patients with \u226570% symptomatic or \u226580% asymptomatic internal carotid stenosis
- Age between 18 and 85 years
- Ability to undergo MRI or CT imaging
- Ability to complete cognitive assessments
You will not qualify if you...
- Inability to provide informed consent
- Previous disabling stroke
- Contralateral carotid occlusion or stenosis greater than 70%
- Systemic disease incompatible with study procedures
- Suspected or confirmed pregnancy
- General contraindications to MRI or CT studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 14 days after enrollment
Participants undergo MRI scans and cognitive assessments to evaluate brain function and carotid artery condition before any intervention.
1 imaging visit and 1 cognitive assessment visit
Long-term Monitoring
Duration - Up to 4 years
Participants are monitored through repeated cognitive assessments and imaging over several years to assess changes in cognitive function and carotid artery status.
Cognitive assessments at baseline or within 2 weeks after assignment, at 44 days, and yearly visits up to 4 years; MRI imaging at baseline and 1 year
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
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Research Team
M
Mingyuan Liu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Carotid artery stenting simulation: from patient-specific images to finite element analysis.
F Auricchio, M Conti, M De Beule...
https://pubmed.ncbi.nlm.nih.gov/21067964Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations.
Michele Conti, Denis Van Loo, Ferdinando Auricchio...
https://pubmed.ncbi.nlm.nih.gov/21679082Patient-specific finite element analysis of carotid artery stenting: a focus on vessel modeling.
F Auricchio, M Conti, A Ferrara...
https://pubmed.ncbi.nlm.nih.gov/23729192Haemodynamic impact of stent-vessel (mal)apposition following carotid artery stenting: mind the gaps!
G De Santis, M Conti, B Trachet...
https://pubmed.ncbi.nlm.nih.gov/22149183A computational study of the hemodynamic impact of open- versus closed-cell stent design in carotid artery stenting.
Gianluca De Santis, Bram Trachet, Michele Conti...
https://pubmed.ncbi.nlm.nih.gov/23578331Flow effects on coagulation and thrombosis.
James J Hathcock
https://pubmed.ncbi.nlm.nih.gov/16741150Overview: temporal and spatial relationships in shear stress-mediated endothelial signalling.
P F Davies
https://pubmed.ncbi.nlm.nih.gov/9226302Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke.
Michael Böhm, Daniel Cotton, Lydia Foster...
https://pubmed.ncbi.nlm.nih.gov/22922507Cognitive testing in patients undergoing carotid endarterectomy.
C D Irvine, F V Gardner, A H Davies...
https://pubmed.ncbi.nlm.nih.gov/9587331