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

NCT01021319 | Completed DMC

• 1 other identifier: PRE-FLAIR
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ischemic Stroke

Keywords

ischemic stroke; thrombolysis; magnetic resonance imaging; diffusion weighted imaging; fluid attenuated inversion recovery; time window

Outcome Measures

Primary Outcomes (1)

• Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours

  on admission

Secondary Outcomes (1)

• Predictors of a "negative FLAIR" in acute ischemic stroke

  on admission

Study Arms (1)

Acute ischemic stroke

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Contraindications against MRI

Sponsors & Collaborators

• Götz Thomalla, MD: lead
• Else Kröner-Fresenius-Stiftung (Foundation): collaborator
• Stroke Imaging Repositoy (STIR): collaborator
• MR Stroke Group: collaborator

Study Sites (2)

Charite Clinical Center

Berlin, 10117, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, 22524, Germany

Location

Related 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, 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.

  PMID: 21978972 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Götz Thomalla, MD

  Uinversity Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Götz Thomalla

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 26, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

DE (2)