Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke

NCT02309970 | Unknown

• 1 other identifier: GR 05 - 14
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. CTP helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment. 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke

  three month

Study Arms (3)

Conservative

patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology

Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran

IV tPA

patient will receive intravenous thrombolysis treatment

Drug: alteplase

Endovascular treatment

patient who will receive endovascular treatment

Procedure: endovascular

Interventions

acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran DRUG

subject in this group will receive oral treatment with anti platelet drug

Also known as: Aspirin, Plavix, Coumadin, Eliquis,Xarelto, Pradaxa, Sintrom

Conservative

alteplase DRUG

subject in this group will receive intravenous tPA

IV tPA

endovascular PROCEDURE

Also known as: subject in this group will undergo mechanical thrombectomy

Endovascular treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

men and women admittedto the emergency room at Rabin Medical Center, Beilinson Campus and hospitalized at the neurology department.

You may qualify if:

• NIHSS\>=8
• up to 6 hours from event onset

You may not qualify if:

• mRS\>= 3 before the start of the event
• life expectency \<1 year because other disability disease

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petach Tiqva, Central District, 49100, Israel

Location

Related Publications (11)

• 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.

  PMID: 22075524 BACKGROUND

• 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.

  PMID: 11546885 RESULT

• 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.

  PMID: 7477192 RESULT

• 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.

  PMID: 18815396 RESULT

• 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.

  PMID: 10591382 RESULT

• 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.

  PMID: 12917889 RESULT

• 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.

  PMID: 22435369 RESULT

• 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.

  PMID: 18705914 RESULT

• 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.

  PMID: 23264523 RESULT

• 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.

  PMID: 23493340 RESULT

• 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.

  PMID: 22015331 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; apixaban; Rivaroxaban; Dabigatran; Clopidogrel; Warfarin; Acenocoumarol; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiophenes; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ticlopidine; Thienopyridines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Guy Raphaeli, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Raphaeli, MD

CONTACT

972-50-4065626; guyre@clalit.org.il

Ophir Keret, MD

CONTACT

972-3-9377080; ophirke@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Guy Raphaeli

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

IL (1)