CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis

Stroke Clinical Trial

— CT-DEFINE  

Official title:

Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463281
• Other study ID #: 23211204
• Status: Completed
• Phase: N/A
• First received: April 19, 2007
• Last updated: May 13, 2009
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Germany	University of Dresden, Dept of Neurology	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale scores 0-2		90 days	No