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)

• ClinicalTrials.gov Identifier: NCT01021319
• Recruitment Status: Completed
• First Posted: November 26, 2009
• Last Update Posted: April 16, 2019
• Sponsor: Götz Thomalla, MD
• Collaborators: Else Kröner-Fresenius-Stiftung (Foundation); Stroke Imaging Repositoy (STIR); MR Stroke Group
• Information provided by (Responsible Party): Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: November 24, 2009
• First Posted Date: November 26, 2009
• Last Update Posted Date: April 16, 2019
• Study Start Date: September 2009
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 25, 2009): Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours [ Time Frame: on admission ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 25, 2009): Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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)
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined and well known symptom onset
• Condition: Acute Ischemic Stroke
• Intervention: Not Provided

Study Groups/Cohorts

Acute ischemic stroke

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

• Publications *: 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, Kohrmann M, Endres M, Kang DW, Dousset V, Sorensen AG, Liebeskind DS, Fiebach JB, Fiehler J, Gerloff C; STIR and VISTA Imaging Investigators. DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4.5 h of symptom onset (PRE-FLAIR): a multicentre observational study. Lancet Neurol. 2011 Nov;10(11):978-86. doi: 10.1016/S1474-4422(11)70192-2. Epub 2011 Oct 4.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2012): 643
• Original Estimated Enrollment (submitted: November 25, 2009): 500
• Actual Study Completion Date: May 2010
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01021319
• Other Study ID Numbers: PRE-FLAIR
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Götz Thomalla, MD, Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Dr. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
• Current Study Sponsor: Götz Thomalla, MD
• Original Study Sponsor: Universitätsklinikum Hamburg-Eppendorf

Collaborators

• Else Kröner-Fresenius-Stiftung (Foundation)
• Stroke Imaging Repositoy (STIR)
• MR Stroke Group

Investigators

• Principal Investigator: Götz Thomalla, MD; Uinversity Medical Center Hamburg-Eppendorf

• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: April 2019