Protocol for the perfusion and angiography imaging sub- study of the Third International Stroke Trial (IST-3) of alteplase treatment within six hours of acute ischaemic stroke.


Joanna Wardlaw, Reudiger von Krummer, Trevor Carpenter, Mark Parsons, Richard Lindley, Geoff Cohen, Veronica Murray, Adam Kobayashi, Andre Peeters, Francesca Chappell and Peter Sandercock.   

Abstract
Rationale: Intravenous thrombolysis with recombinant tissue plasminogen Activator (rt- PA) improves outcomes in patients treated early after stroke but at the risk of causing intracranial haemorrhage. Restricting rt-P A use to patients with evidence of still salvageable tissue, or with definite arterial occlusion, might help reduce risk, increase benefit and identify patients for treatment at late time windows.
Aims: To determine if perfusion or angiographic imaging with CT or MR help identify patients who are more likely to benefit from rt-PA in the context of a large multicentre randomised trial of rt-PA given within six hours of onset of acute ischaemic stroke, the Third International Stroke Trial (IST-3).
Design: IST-3 is a prospective multicentre randomised controlled trial testing rt-PA (0.9mg/kg, maximum dose 90mg) started up to six hours after onset of acute ischaemic stroke, in patients with no clear indication for or contraindication to rt-PA. Brain imaging (CT or MR) was mandatory pre-randomisation to exclude haemorrhage. Scans were read centrally, blinded to treatment and clinical information. In centres where perfusion and/or angiography imaging were used routinely in stroke, these images were also collected centrally, processed and assessed using validated visual scores and computational measures.
Study Outcomes: The primary outcome in IST-3 is alive and independent (Oxford Handicap Score 0-2) at 6 months; secondary outcomes are symptomatic and fatal intracranial haemorrhage, early and late death. The perfusion and angiography study additionally will examine interactions between rt-PA and clinical outcomes, infarct growth and recanalisation in the presence or absence of perfusion lesions and/or arterial occlusion at presentation. The study is registered ISRCTN25765518. 

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Protocol for the perfusion and angiography imaging sub- study of the Third International Stroke Trial (IST-3) of alteplase treatment within six hours of acute ischaemic stroke. Reviewed by Carmen Lahiff-Jenkins on Monday, August 20, 2012 Rating: 5

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