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Identification of Stroke Patients ≤ 3 and ≤ 4.5 Hours of Symptom Onset by Fluid Attenuated Inversion Recovery (FLAIR) Imaging and Diffusion Weighted Imaging (DWI) (PRE-FLAIR)

This study has been completed.
Sponsor:
Collaborators:
Else Kröner-Fresenius-Stiftung (Foundation)
Stroke Imaging Repositoy (STIR)
MR Stroke Group
Information provided by (Responsible Party):
Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01021319
First received: November 24, 2009
Last updated: January 31, 2012
Last verified: January 2012

November 24, 2009
January 31, 2012
September 2009
May 2010   (final data collection date for primary outcome measure)
Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours [ Time Frame: on admission ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021319 on ClinicalTrials.gov Archive Site
Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Identification of Stroke Patients ≤ 3 and ≤ 4.5 Hours of Symptom Onset by Fluid Attenuated Inversion Recovery (FLAIR) Imaging and Diffusion Weighted Imaging (DWI)
PREdictive Value of FLAIR and DWI for the Identification of Acute Ischemic Stroke Patients ≤ 3 and ≤ 4.5 h of Symptom Onset - a Multicenter Observational Study

The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of symptom onset in a large multicenter study hours of ischemic stroke. The investigators hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR ("DWI-FLAIR mismatch") will identify patients ≤ 3 hours of symptom onset with >80% specificity and positive predictive value.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined and well known symptom onset

Acute Ischemic Stroke
Not Provided
Acute ischemic stroke
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined andwell-known symptom onset.
Thomalla G, Cheng B, Ebinger M, Hao Q, Tourdias T, Wu O, Kim JS, Breuer L, Singer OC, Warach S, Christensen S, Treszl A, Forkert ND, Galinovic I, Rosenkranz M, Engelhorn T, Köhrmann M, Endres M, Kang DW, Dousset V, Sorensen AG, Liebeskind DS, Fiebach JB, Fiehler J, Gerloff C; STIR and VISTA Imaging Investigators. DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4·5 h of symptom onset (PRE-FLAIR): a multicentre observational study. Lancet Neurol. 2011 Nov;10(11):978-86. doi: 10.1016/S1474-4422(11)70192-2. Epub 2011 Oct 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
643
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute ischemic stroke (proven by initial or follow-up MRI)
  • Well defined and known symptom onset
  • Stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) sequences performed within 12 hours of symptom onset
  • Informed consent

Exclusion Criteria:

  • Contraindications against MRI
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01021319
PRE-FLAIR
Yes
Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
Dr. med. Götz Thomalla
  • Else Kröner-Fresenius-Stiftung (Foundation)
  • Stroke Imaging Repositoy (STIR)
  • MR Stroke Group
Principal Investigator: Götz Thomalla, MD Uinversity Medical Center Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP