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

This study has been completed.

Sponsor:

Information provided by:

Dresden University of Technology

ClinicalTrials.gov Identifier:

NCT00463281

First received: April 19, 2007

Last updated: May 13, 2009

Last verified: January 2009

History of Changes

Purpose

Aim of this study is to define a CT-based "tissue window" for stroke thrombolysis. Our primary hypothesis is that

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
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

Further study details as provided by Dresden University of Technology:

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

Dresden University of Technology

Investigators

Principal Investigator:

Imanuel Dzialowski, MD

University of Dresden, Dept of Neurology

More Information

Publications:

Pepper EM, Parsons MW, Bateman GA, Levi CR. CT perfusion source images improve identification of early ischaemic change in hyperacute stroke. J Clin Neurosci. 2006 Feb;13(2):199-205. Epub 2006 Feb 3.

Parsons MW, Pepper EM, Bateman GA, Wang Y, Levi CR. Identification of the penumbra and infarct core on hyperacute noncontrast and perfusion CT. Neurology. 2007 Mar 6;68(10):730-6.

Hill MD, Rowley HA, Adler F, Eliasziw M, Furlan A, Higashida RT, Wechsler LR, Roberts HC, Dillon WP, Fischbein NJ, Firszt CM, Schulz GA, Buchan AM; PROACT-II Investigators. Selection of acute ischemic stroke patients for intra-arterial thrombolysis with pro-urokinase by using ASPECTS. Stroke. 2003 Aug;34(8):1925-31. Epub 2003 Jul 3.

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 Dresden University of Technology:

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 May 19, 2013

To Top