CT Based Definition of a Tissue Window for Acute Stroke T... | NCT00463281

Studies
CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis

NCT00463281

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

May 14, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Apr 19, 2007

First Submission Date that Met QC Criteria

Apr 19, 2007

First Posted Date

Apr 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2009

Last Update Posted Date

May 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Measure	Description	Time Frame
modified Rankin Scale scores 0-2		90 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Ischemic stroke patients presenting within 12 hrs from symptom onset

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Imanuel Dzialowski, MD	University of Dresden, Dept of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Dresden, Dept of Neurology		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16459089	Background	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.
17339580	Background	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.

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases