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

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ClinicalTrials.gov Identifier: NCT00463281
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : May 14, 2009
Sponsor:
Information provided by:
Technische Universität Dresden

Brief Summary:

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.

Condition or disease
Stroke

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2009



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463281


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