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

Acute Ischemic Stroke

Study Type: Observational
Study Design: 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

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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:
  • Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ]

Enrollment: 643
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Acute ischemic stroke
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined andwell-known symptom onset.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01021319

Charite Clinical Center
Berlin, Germany, 10117
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 22524
Sponsors and Collaborators
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
  More Information

Responsible Party: Dr. med. Götz Thomalla, PD Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01021319     History of Changes
Other Study ID Numbers: PRE-FLAIR
Study First Received: November 24, 2009
Last Updated: January 31, 2012

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
ischemic stroke
magnetic resonance imaging
diffusion weighted imaging
fluid attenuated inversion recovery
time window

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on May 25, 2017