StrokeNCT03216369
Short- and Long-Term Hemodynamic Effects of Carotid Endarterectomy and Carotid Artery Stenting
An observational study of Stroke, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MRI
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symtomatic patients with unilateral severe internal carotid artery (ICA) stenosis.
Who may be able to join
- 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
Who cannot join
- Intracranial hemorrhage
- 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
Trial locations and contacts
1 site in 1 country.
Jinhao Lyu, M.D. contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jinhao Lyu, BS, +8613391851857, lvjinhao@hotmail.com
About this study
Official title: Short- and Long-Term Hemodynamic Effects Revealed by Arterial Spin Labeling MRI of Carotid Endarterectomy and Carotid Artery Stenting
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.
Read the 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：
- Pseudo-continuous arterial spin labeling (pCASL) with post labeling delay (PLD) of 2.0s evaluation of cerebral blood flow in target downstream territory.
- FLAIR hyperintensity vascular sign.
- 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
- Stroke
- Being tested
- MRI
- Keywords
- Arterial Spin Labeling, MRI, Perfusion, Carotid artery stenting, Carotid endarterectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI perfusion imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (1)
Hyperperfusion Syndrome
The patients will be monitored whether they experienced hyperperfusion syndrome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study startNov 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, M.D.,Ph.D., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216369
- Sponsor's protocol ID
- CEA/CAS-Radiology-ChinaPLAGH
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-Term Hemodynamic Effects Revealed by Arterial Spin Labeling MRI of Carotid Endarterectomy and Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT03216369
- Acronym / sponsor ID
- CEA/CAS-Radiology-ChinaPLAGH
- Conditions
- Stroke
- Keywords
- Arterial Spin Labeling, MRI, Perfusion, Carotid artery stenting, Carotid endarterectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- Pseudo-continuous arterial spin labeling (pCASL) with post labeling delay (PLD) of 2.0s evaluation of cerebral blood flow in target downstream territory.
- FLAIR hyperintensity vascular sign.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carotid artery stenting and carotid endarterectomy | – | Other: MRISymptomatic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symtomatic patients with unilateral severe internal carotid artery (ICA) stenosis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Intracranial hemorrhage
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI perfusion imaging | Other | carotid artery stenting and carotid endarterectomy |
Primary outcome
Ischemic Event
Time frame: Up to 1 year
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.
1 secondary outcome
Hyperperfusion Syndrome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhao Lyu, M.D. contact
Xin Lou, M.D.,Ph.D. study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yina Lan, M.D. (+86 17326826301, 729992938@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic Event (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.