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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01021319
• Date of registration: 24/11/2009
• Prospective Registration: No
• Primary sponsor: Götz Thomalla, MD
• Public title: 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
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 643
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01021319
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Götz Thomalla, MD
• Affiliation: Uinversity Medical Center Hamburg-Eppendorf

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Ischemic Stroke

Primary Outcome(s)

Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients =3 and =4.5 hours [Time Frame: on admission]

Secondary Outcome(s)

Predictors of a "negative FLAIR" in acute ischemic stroke [Time Frame: on admission]

Secondary ID(s)

PRE-FLAIR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stroke Imaging Repositoy (STIR)

Else Kröner-Fresenius-Stiftung (Foundation)

MR Stroke Group