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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00463281
First received: April 19, 2007
Last updated: May 13, 2009
Last verified: January 2009

April 19, 2007
May 13, 2009
January 2007
January 2008   (final data collection date for primary outcome measure)
modified Rankin Scale scores 0-2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00463281
23211204
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP