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

Götz Thomalla, MD

Status: Completed

Conditions: Acute Ischemic Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01021319

PRE-FLAIR

Details and patient eligibility

About

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.

Enrollment: 643 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

643 participants in 1 patient group

Acute ischemic stroke

Description:

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