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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)

This study has been completed.
Sponsor:
Collaborators:
Else Kröner-Fresenius-Stiftung (Foundation)
Stroke Imaging Repositoy (STIR)
MR Stroke Group
Information provided by (Responsible Party):
Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01021319
First received: November 24, 2009
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Acute Ischemic Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Specificity (and 95% CI) of "DWI-FLAIR-mismatch" for the identification of patients ≤3 and ≤4.5 hours [ Time Frame: on admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ] [ Designated as safety issue: No ]

Enrollment: 643
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute ischemic stroke
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined andwell-known symptom onset.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021319

Locations
Germany
Charite Clinical Center
Berlin, Germany, 10117
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 22524
Sponsors and Collaborators
Dr. med. Götz Thomalla
Else Kröner-Fresenius-Stiftung (Foundation)
Stroke Imaging Repositoy (STIR)
MR Stroke Group
Investigators
Principal Investigator: Götz Thomalla, MD Uinversity Medical Center Hamburg-Eppendorf
  More Information

Publications:

Responsible Party: Dr. med. Götz Thomalla, PD Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01021319     History of Changes
Other Study ID Numbers: PRE-FLAIR
Study First Received: November 24, 2009
Last Updated: January 31, 2012
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
ischemic stroke
thrombolysis
magnetic resonance imaging
 diffusion weighted imaging
fluid attenuated inversion recovery
time window

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013