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

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

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis

Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • modified Rankin Scale scores 0-2 [ Time Frame: 90 days ]

Estimated Enrollment: 100
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ischemic stroke patients presenting within 12 hrs from symptom onset

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
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Please refer to this study by its identifier: NCT00463281

University of Dresden, Dept of Neurology
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Imanuel Dzialowski, MD University of Dresden, Dept of Neurology
  More Information

Responsible Party: Imanuel Dzialowski, MD, University of Dresden Identifier: NCT00463281     History of Changes
Other Study ID Numbers: 23211204
Study First Received: April 19, 2007
Last Updated: May 13, 2009

Keywords provided by Technische Universität Dresden:
stroke, ischemic
computed tomography

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 20, 2017