CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis

NCT ID: NCT00463281

Last Updated: 2009-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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University of Dresden

Principal Investigators

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Imanuel Dzialowski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dresden, Dept of Neurology

Locations

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University of Dresden, Dept of Neurology

Dresden, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1016/j.jocn.2005.03.030. Epub 2006 Feb 3.

Reference Type BACKGROUND
PMID: 16459089 (View on PubMed)

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. doi: 10.1212/01.wnl.0000256366.86353.ff.

Reference Type BACKGROUND
PMID: 17339580 (View on PubMed)

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. doi: 10.1161/01.STR.0000082483.37127.D0. Epub 2003 Jul 3.

Reference Type BACKGROUND
PMID: 12843342 (View on PubMed)

Other Identifiers

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23211204

Identifier Type: -

Identifier Source: org_study_id

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