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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014