Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting
NCT ID: NCT03216369
Last Updated: 2017-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2015-11-30
2019-12-31
Brief Summary
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Detailed Description
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Patients with unilateral severe internal carotid artery (ICA) stenosis of stroke eligible were enrolled who underwent CAS vs CEA.All patients underwent previous scan in 7 days before CAS and CEA and consecutive scan once per 24 hours after CAS and CEA.
Baseline characteristics of patients were recorded including age,gender, hypertension, hypercholesterolemia, diabetes melitus, smoking, obesity, qualifying stroke event.
Protocols:
MRI scan protocols T2 weighted image,T1 weighted image,diffusion weighted image(DWI),fluid-attenuated inversion recovery (FLAIR),arterial spin labeling(ASL) with Post labeling delay (PLD) of 2.0s,Territory ASL(TASL)(PLD=2.0s),3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).
Imaging evaluation:
1. Pseudo-continuous arterial spin labeling (pCASL) with post labeling delay (PLD) of 2.0s evaluation of cerebral blood flow in target downstream territory.
2. FLAIR hyperintensity vascular sign.
3. Collateral pattern assessment by Territorial ASL(TASL) (PLD=2.0s).
Treatment strategy:
Patients were randomly treated by CEA(carotid endarterectomy) or CAS(carotid artery stenting).
Follow up:
Patients were followed up every 24 hours after treatment procedure, and would have a repeat MRI scan after 3 months, 6 months and 1 year.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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carotid artery stenting and carotid endarterectomy
Symptomatic patients with unilateral ICA severe stenosis by magnetic resonance angiography were performed 3D pseudo-Continuous Arterial Spin Labeling MRI before and after CAS and CEA.
MRI
MRI perfusion imaging
Interventions
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MRI
MRI perfusion imaging
Eligibility Criteria
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Inclusion Criteria
* lack of contraindications to MRI
* Symptomatic, unilateral ICA stenosis 70-99%;irrelevant stenosis \<50% of contralateral ICA
* TIA or stroke - within 360 days
Exclusion Criteria
* Informed consent not obtained
* Common exclusion for MRI such as patients with claustrophobia
* Patients with poor imaging quality(Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis)
* Bilateral internal carotid artery occlusion
18 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Xin Lou
Chief
Principal Investigators
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Xin Lou, M.D.,Ph.D.
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEA/CAS-Radiology-ChinaPLAGH
Identifier Type: -
Identifier Source: org_study_id
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