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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)

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ClinicalTrials.gov Identifier: NCT01021319
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : April 16, 2019
Else Kröner-Fresenius-Stiftung (Foundation)
Stroke Imaging Repositoy (STIR)
MR Stroke Group
Information provided by (Responsible Party):
Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease
Acute Ischemic Stroke

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Study Type : Observational
Actual Enrollment : 643 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Acute ischemic stroke
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined andwell-known symptom onset.

Primary Outcome Measures :
  1. Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours [ Time Frame: on admission ]

Secondary Outcome Measures :
  1. Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined and well known symptom onset

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021319

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Charite Clinical Center
Berlin, Germany, 10117
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 22524
Sponsors and Collaborators
Götz Thomalla, MD
Else Kröner-Fresenius-Stiftung (Foundation)
Stroke Imaging Repositoy (STIR)
MR Stroke Group
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Principal Investigator: Götz Thomalla, MD Uinversity Medical Center Hamburg-Eppendorf
Publications of Results:
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Responsible Party: Götz Thomalla, MD, PD Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01021319    
Other Study ID Numbers: PRE-FLAIR
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf:
ischemic stroke
magnetic resonance imaging
diffusion weighted imaging
fluid attenuated inversion recovery
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Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes