Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03216369
Status:
UNKNOWN
Last Update Posted:
2017-07-13
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Short- and Long-Term Hemodynamic Effects Revealed by Arterial Spin Labeling MRI of Carotid Endarterectomy and Carotid Artery Stenting
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Patients:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: