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

Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02309970
• Other study ID #: GR 05 - 14
• Status: Not yet recruiting
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 4, 2014
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2014
• Source: Rabin Medical Center
• Contact: Guy Raphaeli, MD
• Phone: 972-50-4065626
• Email: guyre[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• NIHSS>=8

• up to 6 hours from event onset

Exclusion Criteria:

• mRS>= 3 before the start of the event

• life expectency <1 year because other disability disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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

Procedure:
• endovascular

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tiqva	Hamerkaz

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (11)

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. — View Citation

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. — View Citation

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 — View Citation

González 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. — View Citation

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. — View Citation

Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos 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 M — View Citation

Koton S, Bornstein NM, Green MS. Population group differences in trends in stroke mortality in Israel. Stroke. 2001 Sep;32(9):1984-8. — View Citation

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): — View Citation

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. Review. — View Citation

Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995 Dec 14;333(24):1581-7. — View Citation

Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2003;(3):CD000213. Review. Update in: Cochrane Database Syst Rev. 2009;(4):CD000213. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke		three month	No