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

NCT ID: NCT01021319

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

643 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Acute ischemic stroke

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Else Kröner-Fresenius-Stiftung (Foundation)

UNKNOWN

Sponsor Role collaborator

Stroke Imaging Repositoy (STIR)

UNKNOWN

Sponsor Role collaborator

MR Stroke Group

UNKNOWN

Sponsor Role collaborator

Götz Thomalla, MD

OTHER

Sponsor Role lead

Responsible Party

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Götz Thomalla, MD

PD Dr. med. Götz Thomalla

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Götz Thomalla, MD

Role: PRINCIPAL_INVESTIGATOR

Uinversity Medical Center Hamburg-Eppendorf

Locations

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Charite Clinical Center

Berlin, , Germany

Site Status

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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, Kohrmann 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.

Reference Type RESULT
PMID: 21978972 (View on PubMed)

Other Identifiers

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PRE-FLAIR

Identifier Type: -

Identifier Source: org_study_id

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