CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis - Full Text View

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

This study is currently recruiting participants.

Verified by Dresden University of Technology, May 2008

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00463281

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008

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

Contacts

Contact: Imanuel Dzialowski, MD

+49-351-4583565

imanuel.dzialowski@neuro.med.tu-dresden.de

Locations

Germany
University of Dresden, Dept of Neurology	Recruiting
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:	University of Dresden ( Imanuel Dzialowski, MD )
Study ID Numbers:	23211204
Study First Received:	April 19, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00463281
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

stroke, ischemic
computed tomography
thrombolysis

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009