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CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis (CT-DEFINE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463281
First Posted: April 20, 2007
Last Update Posted: May 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
April 19, 2007
April 20, 2007
May 14, 2009
January 2007
January 2008   (Final data collection date for primary outcome measure)
modified Rankin Scale scores 0-2 [ Time Frame: 90 days ]
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Complete list of historical versions of study NCT00463281 on ClinicalTrials.gov Archive Site
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CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis
Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis

Aim of this study is to define a CT-based "tissue window" for stroke thrombolysis. Our primary hypothesis is that

  1. patients with a "tissue window" (favourable non-contrast CT (NCCT) scan and an intracranial occlusion on CT angiography (CTA) or perfusion-CT-mismatch" (area of reduced cerebral blood flow (CBF) > area of reduced cerebral blood volume (CBV)) represent a significant proportion (> 20%)of acute stroke patients and therefore are an important target group for future interventional studies
  2. patients with a "tissue window" suffer an unfavourable outcome (> 50 % mRS =>4 at 3 months)if the occluded artery was not recanalized.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Ischemic stroke patients presenting within 12 hrs from symptom onset
Stroke
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2009
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ischemic anterior circulation stroke
  • last seen normal < 12 hours
  • stroke severity => 3 on the National Institute of Health Stroke Scale
  • multimodal CT stroke protocol performed
  • informed consent obtained

Exclusion Criteria:

  • premorbid modified Rankin Scale score > 3
  • contraindications to contrast media application
  • pregnancy or breast feeding
  • subacute stroke > 50 % of MCA territory
  • CT evidence of non-vascular cause of stroke symptoms
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00463281
23211204
No
Not Provided
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Imanuel Dzialowski, MD, University of Dresden
Technische Universität Dresden
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Principal Investigator: Imanuel Dzialowski, MD University of Dresden, Dept of Neurology
Technische Universität Dresden
January 2009