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
  Purpose

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
Stroke

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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • modified Rankin Scale scores 0-2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Imanuel Dzialowski, MD, University of Dresden
ClinicalTrials.gov Identifier: NCT00463281     History of Changes
Other Study ID Numbers: 23211204
Study First Received: April 19, 2007
Last Updated: May 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014