WAKE-UP

"Efficacy and safety of MRI-based thrombolysis in wake-up stroke: a randomised, double-blind, placebo-controlled trial"

 Coordinatore UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF 

 Organization address address: Martinistrasse 52
city: HAMBURG
postcode: 20246

contact info
Titolo: Prof.
Nome: Christian
Cognome: Gerloff
Email: send email
Telefono: +49 40 7410 52770
Fax: +49 40 7410 56721

 Nazionalità Coordinatore Germany [DE]
 Sito del progetto http://www.wakeup-stroke.eu/
 Totale costo 16˙050˙806 €
 EC contributo 11˙599˙987 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2011-two-stage
 Funding Scheme CP-IP
 Anno di inizio 2011
 Periodo (anno-mese-giorno) 2011-12-01   -   2016-11-30

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF

 Organization address address: Martinistrasse 52
city: HAMBURG
postcode: 20246

contact info
Titolo: Prof.
Nome: Christian
Cognome: Gerloff
Email: send email
Telefono: +49 40 7410 52770
Fax: +49 40 7410 56721

DE (HAMBURG) coordinator 2˙286˙070.00
2    CHARITE - UNIVERSITAETSMEDIZIN BERLIN

 Organization address address: Chariteplatz 1
city: BERLIN
postcode: 10117

contact info
Titolo: Ms.
Nome: Eveline
Cognome: Fraessdorf
Email: send email
Telefono: +49 30 450576024
Fax: +49 30 450576954

DE (BERLIN) participant 1˙389˙587.00
3    UNIVERSITY OF GLASGOW

 Organization address address: University Avenue
city: GLASGOW
postcode: G12 8QQ

contact info
Titolo: Mr.
Nome: Joe
Cognome: Galloway
Email: send email
Telefono: 441413000000
Fax: 441413000000

UK (GLASGOW) participant 1˙171˙858.00
4    KATHOLIEKE UNIVERSITEIT LEUVEN

 Organization address address: Oude Markt 13
city: LEUVEN
postcode: 3000

contact info
Titolo: Ms.
Nome: Sofie
Cognome: Heroes
Email: send email
Telefono: +32 16 329979
Fax: +32 16 326515

BE (LEUVEN) participant 1˙088˙174.00
5    ZYTOSERVICE DEUTSCHLAND GMBH

 Organization address address: ALBERT SCHWEITZER RING 18
city: HAMBURG
postcode: 22045

contact info
Titolo: Dr.
Nome: Mirco
Cognome: Schaecke
Email: send email
Telefono: 4940600000000
Fax: 4940600000000

DE (HAMBURG) participant 963˙830.00
6    ORION CLINICAL SERVICES LTD

 Organization address address: BATH ROAD 7
city: SLOUGH
postcode: SL13UA

contact info
Titolo: Mr.
Nome: Paul
Cognome: Hunter
Email: send email
Telefono: 441754000000
Fax: 441754000000

UK (SLOUGH) participant 907˙526.00
7    AARHUS UNIVERSITETSHOSPITAL

 Organization address address: NORREBROGADE 44
city: AARHUS
postcode: 8000

contact info
Titolo: Mr.
Nome: John
Cognome: Westensee
Email: send email
Telefono: 4589492379

DK (AARHUS) participant 884˙624.00
8    HOSPICES CIVILS DE LYON

 Organization address address: 3 Quai des Celestins
city: LYON
postcode: 69229

contact info
Titolo: Ms.
Nome: Cécile
Cognome: Legros
Email: send email
Telefono: +33 472 40 68 60
Fax: +33 472 40 68 69

FR (LYON) participant 861˙767.00
9    INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA

 Organization address address: AVENIDA DE FRANCA S/N
city: GIRONA
postcode: 17007

contact info
Titolo: Ms.
Nome: Núria
Cognome: Chico
Email: send email
Telefono: 34972940282
Fax: 34972485422

ES (GIRONA) participant 795˙658.00
10    GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG GAB O

 Organization address address: Oskar-von-Miller-Ring 29
city: MUENCHEN
postcode: 80333

contact info
Titolo: Ms.
Nome: Birgit
Cognome: Fuchs
Email: send email
Telefono: 498929000000
Fax: 498929000000

DE (MUENCHEN) participant 492˙400.00
11    Medical Imaging Research Institute

 Organization address address: Vangerowstr. 18
city: Heidelberg
postcode: 69115

contact info
Titolo: Dr.
Nome: Johannes
Cognome: Gregori
Email: send email
Telefono: +49 6221 43338819
Fax: +49 6221 43 33 88 19

DE (Heidelberg) participant 416˙640.00
12    FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V

 Organization address address: Hansastrasse 27C
city: MUENCHEN
postcode: 80686

contact info
Titolo: Mr.
Nome: Christoph
Cognome: Schulte
Email: send email
Telefono: +49 89 1205 2728
Fax: +49 89 1205 7534

DE (MUENCHEN) participant 257˙031.00
13    STROKE ALLIANCE FOR EUROPE

 Organization address address: RUE WASHINGTON 40
city: BRUSSELS
postcode: 1050

contact info
Titolo: Ms.
Nome: Chatarina
Cognome: Lindgren
Email: send email
Telefono: 4642347676

BE (BRUSSELS) participant 84˙822.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

perfusion    symptoms    suffer    lesion    time    hours    guidelines    thrombolysis    designed    occlusion    mri    blind    million    efficacy    imaging    software    treatment    image    waking    public    clinical    patients    outcome    trial    episode    safety    randomised    wake    vessel    placebo    acute    intravenous    determine    enrolled    stroke    double    window    approved   

 Obiettivo del progetto (Objective)

'WAKE-UP is an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based intravenous thrombolysis in patients with wake-up stroke. Every year 1.5 million patients suffer a stroke in the EU. Up to 20% of stroke patients wake up with stroke symptoms. Currently these patients are excluded from thrombolysis which is the only approved specific treatment available for acute stroke. However, recently the potential of MRI to identify patients likely to be within a time-window for thrombolysis (≤4.5 hours) was demonstrated. WAKE-UP will use a specific MRI pattern, i.e. the mismatch between a visible lesion on diffusion weighted imaging (DWI) and a normal fluid attenuated inversion recovery (FLAIR) image, to randomise patients waking up with stroke symptoms to either treatment with Alteplase or placebo. The primary endpoint will be favourable outcome at 3 months. A total of 800 patients will be enrolled in 40 centres in six EU countries. Additional MRI information such as vessel occlusion or perfusion lesion will not be used for enrolment but will be studied as possible modifiers of the response to thrombolysis. Software will be developed to facilitate the processing and analysis of multiparametric stroke MRI and to assist the integration of modern stroke imaging into acute treatment decisions. The trial will be accompanied by activities increasing the awareness for acute stroke in the public and results will be disseminated within the scientific community as well as within the public. WAKE-UP is aimed to promote a paradigm-change in acute stroke treatment, and to provide effective treatment to a large new group of patients. The results of WAKE-UP are expected to change guidelines of acute stroke management and clinical practice. WAKE-UP will help to reduce the burden of stroke related disability in the EU.'

Introduzione (Teaser)

Currently, acute stroke treatment depends on knowing when the symptoms began. A European consortium is working on a method to determine the time window for therapy.

Descrizione progetto (Article)

Every year 1.5 million patients suffer a stroke in the EU. Intravenous thrombolysis with recombinant tissue plasminogen activator is the only effective and approved specific treatment when administered within 4.5 hours of an acute ischaemic stroke episode. In nearly one fifth of the patients it is not possible to estimate the precise time of the episode making them unsuitable for thrombolysis.

The EU-funded http://www.wakeup-stroke.eu/ (WAKE-UP) (Efficacy and safety of MRI-based thrombolysis in wake-up stroke: a randomised, double-blind, placebo-controlled trial) project has been designed for these patients. The consortium is using magnetic resonance imaging (MRI) to determine if stroke patients remain within the 4.5 hour therapeutic window. Based on this technique, patients waking up with stroke symptoms will be randomised for treatment with thrombolysis.

During the first part of the project, image processing and software has been optimised for quantifying lesion volumes in stroke patients. Considerable work has gone into the image training of over 300 clinicians in 58 sites. Over 775 patients have been enrolled in the trial and 280 patients have been randomised. Data analysis is currently in progress, and partners are also examining the effect of thrombolysis depending on vessel occlusion or perfusion lesion.

Overall, the WAKE-UP study addresses the massive and growing health problem of stroke management. The outcome of the clinical trial will provide unquestionable evidence for the efficacy and safety of MRI-based thrombolysis.

It is anticipated that the project findings will change the guidelines of acute stroke management and become immediately implemented, harmonising stroke treatment across the EU. Long term this approach will allow specific treatment recommendations for acute stroke patients with unknown symptom onset. A 10 % absolute increase in the rate of patients with no or minimal deficit after stroke is envisaged for stroke patients through prompt thrombolysis treatment.

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