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

Acute Ischemic Stroke Clinical Trial

— PRE-FLAIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021319
• Other study ID #: PRE-FLAIR
• Status: Completed
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Locations

Country	Name	City	State
Germany	Charite Clinical Center	Berlin
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (4)

Lead Sponsor	Collaborator
Götz Thomalla, MD	Else Kröner-Fresenius-Stiftung (Foundation), MR Stroke Group, Stroke Imaging Repositoy (STIR)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, Köhrmann M, Endres M, Kang DW, Dousset V, Sorensen AG, Liebeskind DS, Fiebach JB, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients =3 and =4.5 hours		on admission
Secondary	Predictors of a "negative FLAIR" in acute ischemic stroke		on admission