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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01021319

Acronym

PRE-FLAIR

Enrollment

643

Registered

2009-11-26

Start date

2009-09-30

Completion date

2010-05-31

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

ischemic stroke, thrombolysis, magnetic resonance imaging, diffusion weighted imaging, fluid attenuated inversion recovery, time window

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Specificity (and 95% CI) of DWI-FLAIR-mismatch for the identification of patients ≤3 and ≤4.5 hours	on admission

Secondary

Measure	Time frame
Predictors of a negative FLAIR in acute ischemic stroke	on admission

Countries

Germany

Outcome results