Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting
1 other identifier
observational
150
1 country
1
Brief Summary
Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect reperfusion for recanalization therapy. And it provides information about absolute CBF (ml 100 g-1 tissue min-1) at the brain tissue level. The aim of the present study was to evaluate the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF alternation and thus to improve the prevention strategy for hyperperfusion syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 13, 2017
July 1, 2017
4.1 years
July 11, 2017
July 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ischemic Event
The patients will be monitored whether they recured ischemic event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
Up to 1 year
Secondary Outcomes (1)
Hyperperfusion Syndrome
3 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Symtomatic patients with unilateral severe internal carotid artery (ICA) stenosis.
You may qualify if:
- informed patient's consent for ICA stenting or endarterectomy
- lack of contraindications to MRI
- Symptomatic, unilateral ICA stenosis 70-99%;irrelevant stenosis \<50% of contralateral ICA
- TIA or stroke - within 360 days
You may not qualify if:
- Intracranial hemorrhage
- Informed consent not obtained
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xin Lou, M.D.,Ph.D.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
November 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 13, 2017
Record last verified: 2017-07