Jämförelse av anti-koagulation och anti-trombocytterapi för intrakraniell vaskulär aterostenos-magnetisk resonanstomografi (CAPTIVA-MRI)
14 juli 2026 uppdaterad av: Yale University
CAPTIVA-MRI är en observationsstudie med multimodal MR-avbildning som är underordnad CAPTIVA-studien [en 3-armad, dubbelblind fas III-studie utförd på cirka 115 StrokeNet-platser som randomiserar patienter med stroke tillskriven 70-99% intrakraniell aterosklerotisk stenos (ICAS) ) till aspirin plus ticagrelor, klopidogrel eller rivaroxaban.]
Det primära målet med denna kompletterande studie är att avgöra om MRI-biomarkörer potentiellt kan identifiera ICAS-patienter som misslyckas med den bästa medicinska behandlingen.
CAPTIVA-MRI-studien utnyttjar CAPTIVA-studiens design och implementering för att fånga information som kommer att informera och underlätta nästa generations ICAS-studier och hanteringen av patienter med ICAS.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
300
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ka-Ho Wong
- Telefonnummer: 801-585-7575
- E-post: ka-ho.wong@hsc.utah.edu
Studera Kontakt Backup
- Namn: Amy Sulken
- E-post: sulkenay@ucmail.uc.edu
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- University of Alabama Hospital
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Huvudutredare:
- Ekaterina Bakradze
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Kontakt:
- Tammy Davis
- Telefonnummer: 205-975-8572
- E-post: trdavis@uabmc.edu
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Har inte rekryterat ännu
- University Of Colorado Hospital
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Kontakt:
- Allison KOPP
- Telefonnummer: 720-848-0000
- E-post: allison.kopp@cuanschutz.edu
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06106
- Har inte rekryterat ännu
- Hartford Hospital
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Kontakt:
- Aditya VAJJA
- Telefonnummer: 860-545-5000
- E-post: Aditya.Vajja@hhchealth.org
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New Haven, Connecticut, Förenta staterna, 06510
- Rekrytering
- Yale New Haven Hospital
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Huvudutredare:
- James Giles
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Kontakt:
- Michael Kampp
- Telefonnummer: 203-737-2073
- E-post: michael.kampp@yale.edu
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- Rekrytering
- MedStar Washington Hospital Center
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Huvudutredare:
- Sana Somani
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Kontakt:
- Wesley Mcclure
- Telefonnummer: 202-877-7000
- E-post: wesley.mcclure@medstar.net
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Florida
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Jacksonville, Florida, Förenta staterna, 32207
- Rekrytering
- Baptist Medical Center Jacksonville
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Huvudutredare:
- Ricardo Hanel
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Kontakt:
- Jefferson Atillo
- E-post: jefferson.atillo@bcmjax.com
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Kontakt:
- Melissa Stratoberdha
- E-post: melissa.stratoberdha@bmcjax.com
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Miami, Florida, Förenta staterna, 33136
- Rekrytering
- Jackson Memorial Hospital, Miami
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Huvudutredare:
- Victor Del Brutto
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Kontakt:
- Erick Lopez
- Telefonnummer: 305-243-6542
- E-post: exl758@med.miami.edu
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Kontakt:
- Iszet Campo-Bustillo
- E-post: lIcampo@med.miami.edu
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Port Saint Lucie, Florida, Förenta staterna, 34987
- Har inte rekryterat ännu
- Cleveland Clinic Tradition Hospital
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Kontakt:
- Jessica Jordan
- Telefonnummer: 772-345-8100
- E-post: jordanj16@ccf.org
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Illinois
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Carbondale, Illinois, Förenta staterna, 62901
- Har inte rekryterat ännu
- SIH Memorial Hospital of Carbondale
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Huvudutredare:
- Andrea Loggini
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Kontakt:
- Jessie Henson
- Telefonnummer: 618-549-0721
- E-post: Jessie.henson@sih.net
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Chicago, Illinois, Förenta staterna, 60637
- Rekrytering
- University Of Chicago Medical Center
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Huvudutredare:
- Tareq Kass-Hout
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Kontakt:
- Elida Romo
- Telefonnummer: 773-702-2039
- E-post: eromo1@bsd.uchicago.edu
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Kontakt:
- Ahmad Chahine
- Telefonnummer: 773-702-1848
- E-post: ahmad.chahine@bsd.uchicago.edu
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Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- University of Illinois Hospital
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Huvudutredare:
- Ali Alaraj, MD
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Kontakt:
- Lucy Rosales
- Telefonnummer: 312-996-2949
- E-post: luzr@uic.edu
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Michigan
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Wyoming, Michigan, Förenta staterna, 49519
- Har inte rekryterat ännu
- Metro Health Hospital
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Kontakt:
- Garrett hilbelink
- Telefonnummer: 616-252-7200
- E-post: garrett.hilbelink@umhwest.org
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- Har inte rekryterat ännu
- M Health Fairview University of Minnesota Medical Center
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Kontakt:
- Nicole DEGERMAN
- Telefonnummer: 855-324-7843
- E-post: deger018@umn.edu
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Missouri
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St Louis, Missouri, Förenta staterna, 63108
- Rekrytering
- Barnes Jewish Hospital
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Kontakt:
- Jill Newgent
- E-post: newgentj@wustl.edu
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Huvudutredare:
- Yan Wang, MD
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Kontakt:
- Alyssa Hiserote
- E-post: calyssa@wustl.edu
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New York
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Buffalo, New York, Förenta staterna, 14203
- Rekrytering
- Buffalo General Medical Center
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Kontakt:
- Annemarie Crumlish
- E-post: ac35@buffalo.edu
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Huvudutredare:
- Amit Kandel
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Manhasset, New York, Förenta staterna, 11030
- Rekrytering
- North Shore University Hospita
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Huvudutredare:
- Rohan Arora
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Kontakt:
- Ayesha Rehman
- E-post: arehman10@northwell.edu
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New York, New York, Förenta staterna, 10032
- Har inte rekryterat ännu
- NYP Columbia University Medical Center
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Kontakt:
- Sandra JAVIER
- Telefonnummer: 212-305-2500
- E-post: smj2163@cumc.columbia.edu
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28203
- Har inte rekryterat ännu
- Carolinas Medical Center
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Huvudutredare:
- Rahul Karamchandani
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Kontakt:
- Anna M Swiatek
- Telefonnummer: 704-355-2000
- E-post: Anna.M.Helms@atriumhealth.org
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Durham, North Carolina, Förenta staterna, 27705
- Har inte rekryterat ännu
- Duke University Hospital
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Kontakt:
- Megan GONZALEZ
- Telefonnummer: 919-684-8111
- E-post: megan.gonzalez@duke.edu
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Ohio
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Akron, Ohio, Förenta staterna, 44307
- Har inte rekryterat ännu
- Cleveland Clinic Akron General
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Kontakt:
- Debra HUDOCK
- Telefonnummer: 330-344-6000
- E-post: HudockD@ccf.org
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- University of Cincinnati Medical Center
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Huvudutredare:
- Yasmin AZIZ
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Kontakt:
- Christina MIHOVA
- Telefonnummer: 513-558-2968
- E-post: mihovaca@ucmail.uc.edu
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Cleveland, Ohio, Förenta staterna, 44106
- Rekrytering
- UH Cleveland Medical Center
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Huvudutredare:
- Sepideh Amin-Hanjani
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Kontakt:
- Mary Andrew
- Telefonnummer: 844-828-2765
- E-post: mary.andrews@uhhospitals.org
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Toledo, Ohio, Förenta staterna, 43608
- Har inte rekryterat ännu
- Mercy St. Vincent Medical Center
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Kontakt:
- Dee TILLEY
- Telefonnummer: 419-251-3232
- E-post: Dee_Tilley@mercy.com
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29203
- Har inte rekryterat ännu
- Prisma Health Richland Hospital
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Kontakt:
- Georgia Taylor
- Telefonnummer: 803-434-7000
- E-post: georgia.taylor@prismahealth.org
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Texas
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Galveston, Texas, Förenta staterna, 77555
- Rekrytering
- University of Texas Medical Branch
-
Kontakt:
- Stephanie ROSE
- Telefonnummer: 409-772-1011
- E-post: sttrose@UTMB.edu
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Houston, Texas, Förenta staterna, 77030
- Har inte rekryterat ännu
- Memorial Hermann Texas Medical Center
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Kontakt:
- AQUINO HERNANDEZ
- Telefonnummer: 713-704-4000
- E-post: Ariana.Victoria.AquinoHernandez@uth.tmc.edu
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Lubbock, Texas, Förenta staterna, 79410
- Har inte rekryterat ännu
- Covenant Medical Center
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Kontakt:
- Katie HODGES
- Telefonnummer: 806-725-0000
- E-post: Katie.hodges@covhs.org
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- Rekrytering
- UVA Medical Center
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Kontakt:
- Leo Waters
- Telefonnummer: 434-924-3627
- E-post: lxw3rw@uvahealth.org
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
ICAS-patienter som nyligen har fått en stroke och inskrivits i CAPTIVA.
Beskrivning
Inklusionskriterier:
- Inskrivning i CAPTIVA-studien: icke-invalidiserande symtomatisk ischemisk infarkt stroke inom 30 dagar sekundärt till 70-99 % stenos av intrakraniell ICA, MCA, BA eller VA
- Möjlighet att erhålla baslinjestudie-MRT inom 14 dagar efter CAPTIVA-rekryteringar
Exklusions kriterier:
- Kan inte eller vill genomgå MRT, inklusive pacemaker eller andra MRT-kontraindikationer enligt American College of Radiologys riktlinjer62
- Gadoliniumkontrastallergi eller akut eller kronisk njursjukdom med eGFR<30 ml/min/1,73m2
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
CAPTIVA-MRI-gruppen
CAPTIVA-patienter med stroke tillskrivs 70-99 % intrakraniell aterosklerotisk stenos (ICAS) till aspirin plus ticagrelor, klopidogrel eller rivaroxaban.
|
Ytterligare MRT till CAPTIVA-studien vid baslinjen och 12 månaders uppföljning
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Etablera ICAS hemodynamiska och plack MRI-biomarkörer som tillförlitliga prediktorer för återkommande ischemisk stroke i det vaskulära territoriet av index stroke.
Tidsram: 12 månader
|
Återkommande ischemisk stroke, definierad som symtomatisk infarkt i index strokeartärens vaskulära territorium.
Detta resultat bedöms centralt i CAPTIVA med hjälp av en American Heart Associations definition av ischemisk stroke
|
12 månader
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David Liebeskind, MD, University of California, Los Angeles
- Huvudutredare: Sepideh Amin-Hanjani, MD, University Hospitals
- Huvudutredare: Rano Chatterjee, MD, Washington University School of Medicine
- Huvudutredare: Adam de Havenon, MD, MS, Yale University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Mossa-Basha M, Hwang WD, De Havenon A, Hippe D, Balu N, Becker KJ, Tirschwell DT, Hatsukami T, Anzai Y, Yuan C. Multicontrast high-resolution vessel wall magnetic resonance imaging and its value in differentiating intracranial vasculopathic processes. Stroke. 2015 Jun;46(6):1567-73. doi: 10.1161/STROKEAHA.115.009037. Epub 2015 May 7.
- Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
- Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.
- Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
- Amin-Hanjani S, Pandey DK, Rose-Finnell L, Du X, Richardson D, Thulborn KR, Elkind MS, Zipfel GJ, Liebeskind DS, Silver FL, Kasner SE, Aletich VA, Caplan LR, Derdeyn CP, Gorelick PB, Charbel FT; Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke Study Group. Effect of Hemodynamics on Stroke Risk in Symptomatic Atherosclerotic Vertebrobasilar Occlusive Disease. JAMA Neurol. 2016 Feb;73(2):178-85. doi: 10.1001/jamaneurol.2015.3772.
- Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
- Hosmer DW, Hosmer T, Le Cessie S, Lemeshow S. A comparison of goodness-of-fit tests for the logistic regression model. Stat Med. 1997 May 15;16(9):965-80. doi: 10.1002/(sici)1097-0258(19970515)16:93.0.co;2-o.
- Suri MF, Johnston SC. Epidemiology of intracranial stenosis. J Neuroimaging. 2009 Oct;19 Suppl 1:11S-6S. doi: 10.1111/j.1552-6569.2009.00415.x.
- Arenillas JF. Intracranial atherosclerosis: current concepts. Stroke. 2011 Jan;42(1 Suppl):S20-3. doi: 10.1161/STROKEAHA.110.597278. Epub 2010 Dec 16.
- Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31.
- Koo J. The Latest Information on Intracranial Atherosclerosis: Diagnosis and Treatment. Interv Neurol. 2015 Oct;4(1-2):48-50. doi: 10.1159/000438779. Epub 2015 Sep 18.
- Banerjee C, Chimowitz MI. Stroke Caused by Atherosclerosis of the Major Intracranial Arteries. Circ Res. 2017 Feb 3;120(3):502-513. doi: 10.1161/CIRCRESAHA.116.308441.
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- Wang YL, Pan YS, Zhao XQ, Wang D, Johnston SC, Liu LP, Meng X, Wang AX, Wang CX, Wang YJ; CHANCE investigators. Recurrent stroke was associated with poor quality of life in patients with transient ischemic attack or minor stroke: finding from the CHANCE trial. CNS Neurosci Ther. 2014 Dec;20(12):1029-35. doi: 10.1111/cns.12329. Epub 2014 Oct 13.
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- Chaturvedi S, Sacco RL. How recent data have impacted the treatment of internal carotid artery stenosis. J Am Coll Cardiol. 2015 Mar 24;65(11):1134-43. doi: 10.1016/j.jacc.2014.12.045.
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- Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd; CREST Investigators. Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis. N Engl J Med. 2016 Mar 17;374(11):1021-31. doi: 10.1056/NEJMoa1505215. Epub 2016 Feb 18.
- Paraskevas KI, Mikhailidis DP, Veith FJ, Spence JD. Definition of Best Medical Treatment in Asymptomatic and Symptomatic Carotid Artery Stenosis. Angiology. 2016 May;67(5):411-9. doi: 10.1177/0003319715624526. Epub 2015 Dec 31.
- Marler JR. NINDS clinical trials in stroke: lessons learned and future directions. Stroke. 2007 Dec;38(12):3302-7. doi: 10.1161/STROKEAHA.107.485144. Epub 2007 Oct 25.
- Mandell DM, Mossa-Basha M, Qiao Y, Hess CP, Hui F, Matouk C, Johnson MH, Daemen MJ, Vossough A, Edjlali M, Saloner D, Ansari SA, Wasserman BA, Mikulis DJ; Vessel Wall Imaging Study Group of the American Society of Neuroradiology. Intracranial Vessel Wall MRI: Principles and Expert Consensus Recommendations of the American Society of Neuroradiology. AJNR Am J Neuroradiol. 2017 Feb;38(2):218-229. doi: 10.3174/ajnr.A4893. Epub 2016 Jul 28.
- Leng X, Wong KS, Liebeskind DS. Evaluating intracranial atherosclerosis rather than intracranial stenosis. Stroke. 2014 Feb;45(2):645-51. doi: 10.1161/STROKEAHA.113.002491. Epub 2014 Jan 7. No abstract available.
- Romano JG, Prabhakaran S, Nizam A, Feldmann E, Sangha R, Cotsonis G, Campo-Bustillo I, Koch S, Rundek T, Chimowitz MI, Liebeskind DS; MyRIAD Investigators. Infarct Recurrence in Intracranial Atherosclerosis: Results from the MyRIAD Study. J Stroke Cerebrovasc Dis. 2021 Feb;30(2):105504. doi: 10.1016/j.jstrokecerebrovasdis.2020.105504. Epub 2020 Dec 1.
- Feldmann E, Wilterdink JL, Kosinski A, Lynn M, Chimowitz MI, Sarafin J, Smith HH, Nichols F, Rogg J, Cloft HJ, Wechsler L, Saver J, Levine SR, Tegeler C, Adams R, Sloan M; Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) Trial Investigators. The Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) trial. Neurology. 2007 Jun 12;68(24):2099-106. doi: 10.1212/01.wnl.0000261488.05906.c1. Epub 2007 Apr 4.
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- Eshtehardi P, Brown AJ, Bhargava A, Costopoulos C, Hung OY, Corban MT, Hosseini H, Gogas BD, Giddens DP, Samady H. High wall shear stress and high-risk plaque: an emerging concept. Int J Cardiovasc Imaging. 2017 Jul;33(7):1089-1099. doi: 10.1007/s10554-016-1055-1. Epub 2017 Jan 10.
- Jeong SK, Lee JY, Rosenson RS. Association between Ischemic Stroke and Vascular Shear Stress in the Carotid Artery. J Clin Neurol. 2014 Apr;10(2):133-9. doi: 10.3988/jcn.2014.10.2.133. Epub 2014 Apr 23.
- Mutsaerts HJ, Palm-Meinders IH, de Craen AJ, Reiber JH, Blauw GJ, van Buchem MA, van der Grond J, Box FM; PROSPER Study Group. Diastolic carotid artery wall shear stress is associated with cerebral infarcts and periventricular white matter lesions. Stroke. 2011 Dec;42(12):3497-501. doi: 10.1161/STROKEAHA.111.614453. Epub 2011 Sep 8.
- Chen Z, Qin H, Liu J, Wu B, Cheng Z, Jiang Y, Liu L, Jing L, Leng X, Jing J, Wang Y, Wang Y. Characteristics of Wall Shear Stress and Pressure of Intracranial Atherosclerosis Analyzed by a Computational Fluid Dynamics Model: A Pilot Study. Front Neurol. 2020 Jan 17;10:1372. doi: 10.3389/fneur.2019.01372. eCollection 2019.
- Wu J, Wang P, Zhou L, Zhang D, Chen Q, Mao C, Su W, Huo Y, Peng J, Yin X, Chen G. Hemodynamics derived from computational fluid dynamics based on magnetic resonance angiography is associated with functional outcomes in atherosclerotic middle cerebral artery stenosis. Quant Imaging Med Surg. 2022 Jan;12(1):688-698. doi: 10.21037/qims-21-337.
- Leng X, Lan L, Ip HL, Abrigo J, Scalzo F, Liu H, Feng X, Chan KL, Fan FSY, Ma SH, Fang H, Xu Y, Li J, Zhang B, Xu Y, Soo YOY, Mok VCT, Yu SCH, Liebeskind DS, Wong KS, Leung TW. Hemodynamics and stroke risk in intracranial atherosclerotic disease. Ann Neurol. 2019 May;85(5):752-764. doi: 10.1002/ana.25456. Epub 2019 Apr 3.
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24 juni 2024
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31 mars 2029
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31 mars 2029
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