Brief 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. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

Study Start

First participant enrolled

January 1, 2014

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

June 19, 2015

Last Update Submit

February 1, 2017

Conditions

Stroke

Keywords

Arterial Spin LabelingMRIAtherosclerotic StenosisCollateral CirculationIschemic stroke

Outcome Measures

Primary Outcomes (1)

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.
Up to 1 year

Secondary Outcomes (1)

modified Rankin Score
3 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Symptomatic and asymptomatic patients with MCA atherosclerotic moderate to severe stenosis(500%-99%) confirmed by conventional angiography or magnetic resonance angiography.

You may qualify if:

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
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

You may not qualify if:

Multiple intracranial arteries stenosis (\> 50%) or occlusion
Less than 2 atherosclerotic risk factors
Pregnancy and other contraindication to MRI scan
Informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chinese PLA General Hospitallead
Beijing Tiantan Hospitalcollaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (5)

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.
PMID: 23920012BACKGROUND
Al-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.
PMID: 22266703BACKGROUND
Liebeskind 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.
PMID: 21157476BACKGROUND
Liebeskind 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.
PMID: 21437932BACKGROUND
Lyu 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.
PMID: 26732570DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Xin Lou, MD, PHD.
Chinese PLA General Hospital
STUDY CHAIR

Central Study Contacts

Jinhao Lyu, B.S.

CONTACT

+86 13391851857 lvjinhao@hotmail.com

Ning Ma, M.D.

CONTACT

+86 13581889908 maning_03@hotmail.com

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Target Duration: 3 Months
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Deputy Chief of Radiology Department

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Collateral Circulation

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations