Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke
NCT ID: NCT02309970
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2014-12-31
2016-03-31
Brief Summary
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The use of CTP in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event.
The importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. But crucial evidence to support the predictive value of CTP to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.
Currently, the use of CTP is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking.
The current guidelines restrict the use of CTP trials and to patients that can't performed MRI scan.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Conservative
patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology
acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran
subject in this group will receive oral treatment with anti platelet drug
IV tPA
patient will receive intravenous thrombolysis treatment
alteplase
subject in this group will receive intravenous tPA
Endovascular treatment
patient who will receive endovascular treatment
endovascular
Interventions
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acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran
subject in this group will receive oral treatment with anti platelet drug
alteplase
subject in this group will receive intravenous tPA
endovascular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* up to 6 hours from event onset
Exclusion Criteria
* life expectency \<1 year because other disability disease
18 Years
85 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Guy Raphaeli
Dr. Guy Raphaeli
Principal Investigators
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Guy Raphaeli, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center
Petach Tiqva, Central District, Israel
Countries
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Central Contacts
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Facility Contacts
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Guy Raphaeli, MD
Role: primary
References
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Bivard A, Spratt N, Levi C, Parsons M. Perfusion computer tomography: imaging and clinical validation in acute ischaemic stroke. Brain. 2011 Nov;134(Pt 11):3408-16. doi: 10.1093/brain/awr257.
Koton S, Bornstein NM, Green MS. Population group differences in trends in stroke mortality in Israel. Stroke. 2001 Sep;32(9):1984-8. doi: 10.1161/hs0901.095407.
National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2003;(3):CD000213. doi: 10.1002/14651858.CD000213.
Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.
Parsons MW. Perfusion CT: is it clinically useful? Int J Stroke. 2008 Feb;3(1):41-50. doi: 10.1111/j.1747-4949.2008.00175.x.
Goyal M, Menon BK, Derdeyn CP. Perfusion imaging in acute ischemic stroke: let us improve the science before changing clinical practice. Radiology. 2013 Jan;266(1):16-21. doi: 10.1148/radiol.12112134. No abstract available.
Gonzalez RG, Copen WA, Schaefer PW, Lev MH, Pomerantz SR, Rapalino O, Chen JW, Hunter GJ, Romero JM, Buchbinder BR, Larvie M, Hirsch JA, Gupta R. The Massachusetts General Hospital acute stroke imaging algorithm: an experience and evidence based approach. J Neurointerv Surg. 2013 May;5 Suppl 1(Suppl 1):i7-12. doi: 10.1136/neurintsurg-2013-010715. Epub 2013 Mar 14.
Abstracts of the 17th European Stroke Conference. Nice, France. May 13-16, 2008. Cerebrovasc Dis. 2008;25 Suppl 2:1-204. doi: 10.1159/000132086. No abstract available.
Other Identifiers
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GR 05 - 14
Identifier Type: -
Identifier Source: org_study_id