Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study

<p>Abstract</p> <p>Background</p> <p>The mismatch between diffusion weighted imaging (DWI) lesion and perfusion imaging (PI) deficit volumes has been used as a surrogate of ischemic penumbra. This pathophysiology-orientated patient selection criterion for acute stroke t...

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Main Authors: Endres Matthias, Martus Peter, Xu Chao, Brunecker Peter, Schmidt Wolf U, Rozanski Michal, Kudo Kohsuke, Jegzentis Kati, Oepen Gabriele, Ebinger Martin, Pittl Sandra, Hotter Benjamin, Jungehülsing Gerhard J, Villringer Arno, Fiebach Jochen B
Format: Article
Language:English
Published: BMC 2009-12-01
Series:BMC Neurology
Online Access:http://www.biomedcentral.com/1471-2377/9/60
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author Endres Matthias
Martus Peter
Xu Chao
Brunecker Peter
Schmidt Wolf U
Rozanski Michal
Kudo Kohsuke
Jegzentis Kati
Oepen Gabriele
Ebinger Martin
Pittl Sandra
Hotter Benjamin
Jungehülsing Gerhard J
Villringer Arno
Fiebach Jochen B
author_facet Endres Matthias
Martus Peter
Xu Chao
Brunecker Peter
Schmidt Wolf U
Rozanski Michal
Kudo Kohsuke
Jegzentis Kati
Oepen Gabriele
Ebinger Martin
Pittl Sandra
Hotter Benjamin
Jungehülsing Gerhard J
Villringer Arno
Fiebach Jochen B
author_sort Endres Matthias
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>The mismatch between diffusion weighted imaging (DWI) lesion and perfusion imaging (PI) deficit volumes has been used as a surrogate of ischemic penumbra. This pathophysiology-orientated patient selection criterion for acute stroke treatment may have the potential to replace a fixed time window. Two recent trials - DEFUSE and EPITHET - investigated the mismatch concept in a multicenter prospective approach. Both studies randomized highly selected patients (n = 74/n = 100) and therefore confirmation in a large consecutive cohort is desirable. We here present a single-center approach with a 3T MR tomograph next door to the stroke unit, serving as a bridge from the ER to the stroke unit to screen all TIA and stroke patients. Our primary hypothesis is that the prognostic value of the mismatch concept is depending on the vessel status. Primary endpoint of the study is infarct growth determined by imaging, secondary endpoints are neurological deficit on day 5-7 and functional outcome after 3 months.</p> <p>Methods and design</p> <p>1000Plus is a prospective, single centre observational study with 1200 patients to be recruited. All patients admitted to the ER with the clinical diagnosis of an acute cerebrovascular event within 24 hours after symptom onset are screened. Examinations are performed on day 1, 2 and 5-7 with neurological examination including National Institute of Health Stroke Scale (NIHSS) scoring and stroke MRI including T2*, DWI, TOF-MRA, FLAIR and PI. PI is conducted as dynamic susceptibility-enhanced contrast imaging with a fixed dosage of 5 ml 1 M Gadobutrol. For post-processing of PI, mean transit time (MTT) parametric images are determined by deconvolution of the arterial input function (AIF) which is automatically identified. Lesion volumes and mismatch are measured and calculated by using the perfusion mismatch analyzer (PMA) software from ASIST-Japan. Primary endpoint is the change of infarct size between baseline examination and day 5-7 follow up.</p> <p>Discussions</p> <p>The aim of this study is to describe the incidence of mismatch and the predictive value of PI for final lesion size and functional outcome depending on delay of imaging and vascular recanalization. It is crucial to standardize PI for future randomized clinical trials as for individual therapeutic decisions and we expect to contribute to this challenging task.</p> <p>Trial Registration</p> <p>clinicaltrials.gov NCT00715533</p>
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spelling doaj.art-c1500b60bca94bf9b5fee39218d365402022-12-21T19:41:32ZengBMCBMC Neurology1471-23772009-12-01916010.1186/1471-2377-9-60Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus studyEndres MatthiasMartus PeterXu ChaoBrunecker PeterSchmidt Wolf URozanski MichalKudo KohsukeJegzentis KatiOepen GabrieleEbinger MartinPittl SandraHotter BenjaminJungehülsing Gerhard JVillringer ArnoFiebach Jochen B<p>Abstract</p> <p>Background</p> <p>The mismatch between diffusion weighted imaging (DWI) lesion and perfusion imaging (PI) deficit volumes has been used as a surrogate of ischemic penumbra. This pathophysiology-orientated patient selection criterion for acute stroke treatment may have the potential to replace a fixed time window. Two recent trials - DEFUSE and EPITHET - investigated the mismatch concept in a multicenter prospective approach. Both studies randomized highly selected patients (n = 74/n = 100) and therefore confirmation in a large consecutive cohort is desirable. We here present a single-center approach with a 3T MR tomograph next door to the stroke unit, serving as a bridge from the ER to the stroke unit to screen all TIA and stroke patients. Our primary hypothesis is that the prognostic value of the mismatch concept is depending on the vessel status. Primary endpoint of the study is infarct growth determined by imaging, secondary endpoints are neurological deficit on day 5-7 and functional outcome after 3 months.</p> <p>Methods and design</p> <p>1000Plus is a prospective, single centre observational study with 1200 patients to be recruited. All patients admitted to the ER with the clinical diagnosis of an acute cerebrovascular event within 24 hours after symptom onset are screened. Examinations are performed on day 1, 2 and 5-7 with neurological examination including National Institute of Health Stroke Scale (NIHSS) scoring and stroke MRI including T2*, DWI, TOF-MRA, FLAIR and PI. PI is conducted as dynamic susceptibility-enhanced contrast imaging with a fixed dosage of 5 ml 1 M Gadobutrol. For post-processing of PI, mean transit time (MTT) parametric images are determined by deconvolution of the arterial input function (AIF) which is automatically identified. Lesion volumes and mismatch are measured and calculated by using the perfusion mismatch analyzer (PMA) software from ASIST-Japan. Primary endpoint is the change of infarct size between baseline examination and day 5-7 follow up.</p> <p>Discussions</p> <p>The aim of this study is to describe the incidence of mismatch and the predictive value of PI for final lesion size and functional outcome depending on delay of imaging and vascular recanalization. It is crucial to standardize PI for future randomized clinical trials as for individual therapeutic decisions and we expect to contribute to this challenging task.</p> <p>Trial Registration</p> <p>clinicaltrials.gov NCT00715533</p>http://www.biomedcentral.com/1471-2377/9/60
spellingShingle Endres Matthias
Martus Peter
Xu Chao
Brunecker Peter
Schmidt Wolf U
Rozanski Michal
Kudo Kohsuke
Jegzentis Kati
Oepen Gabriele
Ebinger Martin
Pittl Sandra
Hotter Benjamin
Jungehülsing Gerhard J
Villringer Arno
Fiebach Jochen B
Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
BMC Neurology
title Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
title_full Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
title_fullStr Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
title_full_unstemmed Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
title_short Prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset - 1000Plus study
title_sort prospective study on the mismatch concept in acute stroke patients within the first 24 h after symptom onset 1000plus study
url http://www.biomedcentral.com/1471-2377/9/60
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