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

Sponsor
Götz Thomalla, MD (Other)
Overall Status
Completed
CT.gov ID
NCT01021319
Collaborator
Else Kröner-Fresenius-Stiftung (Foundation) (Other), Stroke Imaging Repositoy (STIR) (Other), MR Stroke Group (Other)
643
2
8
321.5
40.4

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Sep 1, 2009
    Actual Primary Completion Date :
    May 1, 2010
    Actual Study Completion Date :
    May 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Acute ischemic stroke

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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Predictors of a "negative FLAIR" in acute ischemic stroke [on admission]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Charite Clinical Center Berlin Germany 10117
    2 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

    Investigators

    • Principal Investigator: Götz Thomalla, MD, Uinversity Medical Center Hamburg-Eppendorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Nov 26, 2009
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Keywords provided by Götz Thomalla, MD, PD Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 16, 2019