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)
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
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
- Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours [on admission]
Secondary Outcome Measures
- Predictors of a "negative FLAIR" in acute ischemic stroke [on admission]
Eligibility Criteria
Criteria
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.- PRE-FLAIR