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:
Dr. med. Götz Thomalla
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
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2009 | ||||
| Last Updated Date | January 31, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01021319 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Predictors of a "negative FLAIR" in acute ischemic stroke [ Time Frame: on admission ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| 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 |
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| Condition ICMJE | Acute Ischemic Stroke | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Acute ischemic stroke
Patients with acute ischemic stroke confirmed by acute or follow-up MRI with defined andwell-known symptom onset. |
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| 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, Köhrmann 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. Epub 2011 Oct 4. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 643 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01021319 | ||||
| Other Study ID Numbers ICMJE | PRE-FLAIR | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. med. Götz Thomalla, Universitätsklinikum Hamburg-Eppendorf | ||||
| Study Sponsor ICMJE | Dr. med. Götz Thomalla | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Universitätsklinikum Hamburg-Eppendorf | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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