StrokeNCT02479243
Assessment and Quantification of Collateral by ASL MRI
An observational study of Stroke, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Collateral circulation supports brain tissues to maintain blood perfusion in cerebral ischemic stroke and are of great benefit for a better outcome. A non-invasive approach relative to currently widely used digital subtraction angiography (DSA) is needed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2017
- How long will I take part?
- 3 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic and asymptomatic patients with MCA atherosclerotic moderate to severe stenosis(500%-99%) confirmed by conventional angiography or magnetic resonance angiography.
Who may be able to join
- Ischemic stroke or TIA in anterior circulation within 90 days
- MCA atherosclerotic moderate to severe stenosis(50%-99%) confirmed by conventional angiography or magnetic resonance angiography
- Age >18
- 2 or more atherosclerotic risk factors including hypertension, hypercholesterolemia, diabetes mellitus, cigarette smoking, and obesity
- Medical treatment
- Not receiving stent therapy
- Ability to comply with all studies
Who cannot join
- Multiple intracranial arteries stenosis (> 50%) or occlusion
- Less than 2 atherosclerotic risk factors
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
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: Arterial Spin Labeling MRI Assessment and Quantification of Collateral Circulation in Unilateral Middle Cerebral Artery Atherosclerotic Stenosis
Collateral circulation supports brain tissues to maintain blood perfusion in cerebral ischemic stroke and are of great benefit for a better outcome. A non-invasive approach relative to currently widely used digital subtraction angiography (DSA) is needed. ASL (arterial spin labeling) is a novel perfusion method without contrast agent injection and features both temporal and cerebral blood flow(CBF) information. The investigators applied multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL) MRI and subtraction images were obtained to evaluate the collateral robustness and quantitatively assess the collateral perfusion in patients with unilateral middle cerebral artery atherosclerotic stenosis and the ability to predict future stroke recurrence.
Read the detailed description
Patients with unilateral middle cerebral artery (MCA) moderate to severe stenosis were consecutively enrolled. MRI protocols including diffusion weighted image, magnetic resonance angiography , 3D pCASL with two PLD of 1.5s and 2.5s were performed.
Cerebral blood flow(CBF) map of 3D pCASL with PLD 1.5s and 2.5s were postprocessed on workstation. Subtraction images were obtained by CBF 2.5s subtracted CBF 1.5s. Slices involving MCA downstream territory were equally separated as upper slices,middle slices and inferior slices corresponding to CIS system referring to previous study of Al-Ali F. Slices with residual signal areas more than 1/3 MCA territory involved would count 1, or would be 0. Total ASL collateral score(ASLCS) was calculated from 0-3. Then ,favorable collaterals were graded as total ASLCS 2-3 and poor collaterals were graded as total ASLCS 0-1.
Early-arriving flow perfusion proportion was defined as [CBF 1.5s at lesion side/CBF 2.5s of the contralateral side]×100%. Late-arriving perfusion proportion was defined as [(CBF 2.5s minus CBF 1.5s) at lesion side minus (CBF 2.5s minus CBF 1.5s) at normal side]/CBF 2.5s at the contralateral side ×100%. Antegrade scales and collateral grades were evaluated in patients with conventional angiography. Spearman correlation was analyzed between early-arriving and late-arriving flow and angiographic antegrade and collateral scales.
Baseline characteristics of patients were recorded including age, gender, hypertension,hypercholesterolemia,diabetes mellitus,smoking,obesity,qualifying stroke event, admission National Institute of Health stroke scale (NIHSS), diffusion-weighted image-ASPECTS.
One year stroke event recurrence and three months modified Rankin Scale (mRS) were followed up by neurologist by phone call or face to face.
Multi-variants Logistic Regression is performed to exam whether ASL collateral score and collateral perfusion quantification is significantly correlated with future ischemic event and functional outcome.
- Conditions
- Stroke
- Keywords
- Arterial Spin Labeling, MRI, Atherosclerotic Stenosis, Collateral Circulation, Ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Collateral Circulation | Symptomatic patients with unilateral MCA severe stenosis confirmed ≥ 90% by magnetic resonance angiography or 70-99% by conventional angiography were performed 3D pseudo-Continuous Arterial Spin Labeling MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Event
The patients were monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
Measured: Up to 1 year
Secondary outcomes (1)
modified Rankin Score
mRS of patients with acute or subacute stroke after 3 months were followed up for neurological outcome assessment. mRS < 2 was defined as favorable neurological outcome and mRS ≥ 2 was defined as poor neurological outcome.
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 posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD, PHD., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479243
- Sponsor's protocol ID
- Xin Lou-ChinaPLAGH
- Other IDs
- Jh Lyu
- Status last verified
- Feb 2017
- First submitted
- 19 Jun 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
PubMed 23920012Al-Ali F, Jefferson A, Barrow T, Cree T, Louis S, Luke K, Major K, Nemeth D, Smoker S, Walker S. The capillary index score: rethinking the acute ischemic stroke treatment algorithm. Results from the Borgess Medical Center Acute Ischemic Stroke Registry. J Neurointerv Surg. 2013 Mar;5(2):139-43. doi: 10.1136/neurintsurg-2011-010146. Epub 2012 Jan 19.
PubMed 22266703Liebeskind DS, Cotsonis GA, Saver JL, Lynn MJ, Cloft HJ, Chimowitz MI; Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Investigators. Collateral circulation in symptomatic intracranial atherosclerosis. J Cereb Blood Flow Metab. 2011 May;31(5):1293-301. doi: 10.1038/jcbfm.2010.224. Epub 2010 Dec 15.
PubMed 21157476Liebeskind DS, Cotsonis GA, Saver JL, Lynn MJ, Turan TN, Cloft HJ, Chimowitz MI; Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Investigators. Collaterals dramatically alter stroke risk in intracranial atherosclerosis. Ann Neurol. 2011 Jun;69(6):963-74. doi: 10.1002/ana.22354. Epub 2011 Mar 17.
PubMed 21437932Lyu J, Ma N, Liebeskind DS, Wang DJ, Ma L, Xu Y, Wang T, Miao Z, Lou X. Arterial Spin Labeling Magnetic Resonance Imaging Estimation of Antegrade and Collateral Flow in Unilateral Middle Cerebral Artery Stenosis. Stroke. 2016 Feb;47(2):428-33. doi: 10.1161/STROKEAHA.115.011057. Epub 2016 Jan 5.
PubMed 26732570
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Spin Labeling MRI Assessment and Quantification of Collateral Circulation in Unilateral Middle Cerebral Artery Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT02479243
- Acronym / sponsor ID
- Xin Lou-ChinaPLAGH
- Conditions
- Stroke
- Keywords
- Arterial Spin Labeling, MRI, Atherosclerotic Stenosis, Collateral Circulation, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- 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.
Collateral circulation supports brain tissues to maintain blood perfusion in cerebral ischemic stroke and are of great benefit for a better outcome. A non-invasive approach relative to currently widely used digital subtraction angiography (DSA) is needed. ASL (arterial spin labeling) is a novel perfusion method without contrast agent injection and features both temporal and cerebral blood flow(CBF) information. The investigators applied multiple post labeled delay(PLD) time to pseudo-continuous Arterial Spin Labeling (3D pCASL) MRI and subtraction images were obtained to evaluate the collateral robustness and quantitatively assess the collateral perfusion in patients with unilateral middle cerebral artery atherosclerotic stenosis and the ability to predict future stroke recurrence.
Detailed description
Patients with unilateral middle cerebral artery (MCA) moderate to severe stenosis were consecutively enrolled. MRI protocols including diffusion weighted image, magnetic resonance angiography , 3D pCASL with two PLD of 1.5s and 2.5s were performed.
Cerebral blood flow(CBF) map of 3D pCASL with PLD 1.5s and 2.5s were postprocessed on workstation. Subtraction images were obtained by CBF 2.5s subtracted CBF 1.5s. Slices involving MCA downstream territory were equally separated as upper slices,middle slices and inferior slices corresponding to CIS system referring to previous study of Al-Ali F. Slices with residual signal areas more than 1/3 MCA territory involved would count 1, or would be 0. Total ASL collateral score(ASLCS) was calculated from 0-3. Then ,favorable collaterals were graded as total ASLCS 2-3 and poor collaterals were graded as total ASLCS 0-1.
Early-arriving flow perfusion proportion was defined as [CBF 1.5s at lesion side/CBF 2.5s of the contralateral side]×100%. Late-arriving perfusion proportion was defined as [(CBF 2.5s minus CBF 1.5s) at lesion side minus (CBF 2.5s minus CBF 1.5s) at normal side]/CBF 2.5s at the contralateral side ×100%. Antegrade scales and collateral grades were evaluated in patients with conventional angiography. Spearman correlation was analyzed between early-arriving and late-arriving flow and angiographic antegrade and collateral scales.
Baseline characteristics of patients were recorded including age, gender, hypertension,hypercholesterolemia,diabetes mellitus,smoking,obesity,qualifying stroke event, admission National Institute of Health stroke scale (NIHSS), diffusion-weighted image-ASPECTS.
One year stroke event recurrence and three months modified Rankin Scale (mRS) were followed up by neurologist by phone call or face to face.
Multi-variants Logistic Regression is performed to exam whether ASL collateral score and collateral perfusion quantification is significantly correlated with future ischemic event and functional outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collateral Circulation | – | –Symptomatic patients with unilateral MCA severe stenosis confirmed ≥ 90% by magnetic resonance angiography or 70-99% by conventional angiography were performed 3D pseudo-Continuous Arterial Spin Labeling MRI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic and asymptomatic patients with MCA atherosclerotic moderate to severe stenosis(500%-99%) confirmed by conventional angiography or magnetic resonance angiography.
Key inclusion criteria (7 listed)
- Ischemic stroke or TIA in anterior circulation within 90 days
- MCA atherosclerotic moderate to severe stenosis(50%-99%) confirmed by conventional angiography or magnetic resonance angiography
- Age >18
- 2 or more atherosclerotic risk factors including hypertension, hypercholesterolemia, diabetes mellitus, cigarette smoking, and obesity
- Medical treatment
Key exclusion criteria (4 listed)
- Multiple intracranial arteries stenosis (> 50%) or occlusion
- Less than 2 atherosclerotic risk factors
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroke Event
Time frame: Up to 1 year
The patients were monitored whether they recured ischemic stroke event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.
1 secondary outcome
modified Rankin Score
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 3 Feb 2017.
- Background: PubMed 23920012Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
- Background: PubMed 22266703Al-Ali F, Jefferson A, Barrow T, Cree T, Louis S, Luke K, Major K, Nemeth D, Smoker S, Walker S. The capillary index score: rethinking the acute ischemic stroke treatment algorithm. Results from the Borgess Medical Center Acute Ischemic Stroke Registry. J Neurointerv Surg. 2013 Mar;5(2):139-43. doi: 10.1136/neurintsurg-2011-010146. Epub 2012 Jan 19.
- Background: PubMed 21157476Liebeskind DS, Cotsonis GA, Saver JL, Lynn MJ, Cloft HJ, Chimowitz MI; Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Investigators. Collateral circulation in symptomatic intracranial atherosclerosis. J Cereb Blood Flow Metab. 2011 May;31(5):1293-301. doi: 10.1038/jcbfm.2010.224. Epub 2010 Dec 15.
- Background: PubMed 21437932Liebeskind DS, Cotsonis GA, Saver JL, Lynn MJ, Turan TN, Cloft HJ, Chimowitz MI; Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Investigators. Collaterals dramatically alter stroke risk in intracranial atherosclerosis. Ann Neurol. 2011 Jun;69(6):963-74. doi: 10.1002/ana.22354. Epub 2011 Mar 17.
- Derived from this study: PubMed 26732570Lyu J, Ma N, Liebeskind DS, Wang DJ, Ma L, Xu Y, Wang T, Miao Z, Lou X. Arterial Spin Labeling Magnetic Resonance Imaging Estimation of Antegrade and Collateral Flow in Unilateral Middle Cerebral Artery Stenosis. Stroke. 2016 Feb;47(2):428-33. doi: 10.1161/STROKEAHA.115.011057. Epub 2016 Jan 5.
- Individual participant dataSharing planned: No
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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.
Xin Lou, MD, PHD. 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 7 inclusion and 4 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 3 Feb 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 Jinhao Lyu, B.S. (+86 13391851857, lvjinhao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke 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?
On the ClinicalTrials.gov record for NCT02479243, which also lists 5 linked publications.
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 3 Feb 2017.