Penumbra and re-canalization acute computed tomography in ischemic stroke evaluation: PRACTISE study protocol

Salwa El Tawil, Joanna Wardlaw, Ian Ford, Grant Mair, Tom Robinson, Lalit Kalra, Keith W Muir

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Rationale

Multimodal imaging, including computed tomography angiography and computed tomography perfusion imaging, yields additional information on intracranial vessels and brain perfusion and can differentiate between ischemic core and penumbra which may affect patient selection for intravenous thrombolysis.
Hypothesis

The use of multimodal imaging will increase the number of patients receiving intravenous thrombolysis and lead to better treatment outcomes.
Sample size

400 patients.
Methods and design

PRACTISE is a prospective, multicenter, randomized, controlled trial in which patients presenting within 4.5 h of symptom onset are randomized to either the current evidence-based imaging (NCCT alone) or additional multimodal computed tomography imaging (NCCT + computed tomography angiography + computed tomography perfusion). Clinical decisions on intravenous recombinant tissue plasminogen activator are documented. Total imaging time in both arms and time to initiation of treatment delivery in those treated with intravenous recombinant tissue plasminogen activator, is recorded. Follow-up will include brain imaging at 24 h to document infarct size, the presence of edema and the presence of intra-cerebral hemorrhage. Clinical evaluations include NIHSS score at baseline, 24 h and day 7 ± 2, and mRS at day 90 to define functional outcomes.
Study outcomes

The primary outcome is the proportion of patients receiving intravenous recombinant tissue plasminogen activator. Secondary end-points evaluate times to decision-making, comparison of different image processing software and clinical outcomes at three months.
Discussion

Multimodal computed tomography is a widely available tool for patient selection for revascularization therapy, but it is currently unknown whether the use of additional imaging in all stroke patients is beneficial. The study opened for recruitment in March 2015 and will provide data on the value of multimodal imaging in treatment decisions for acute stroke.
Keywords Acute stroke, stroke imaging, multimodal computed tomography
Original languageEnglish
JournalInternational Journal of Stroke
Early online date14 Mar 2017
DOIs
Publication statusE-pub ahead of print - 14 Mar 2017

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