NCT00463281

Brief Summary

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

  1. 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. 2.patients with a "tissue window" suffer an unfavourable outcome (\> 50 % mRS =\>4 at 3 months)if the occluded artery was not recanalized.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 14, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

April 19, 2007

Last Update Submit

May 13, 2009

Conditions

Stroke

Keywords

stroke, ischemiccomputed tomographythrombolysis

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale scores 0-2

    90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ischemic stroke patients presenting within 12 hrs from symptom onset

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dresden, Dept of Neurology

Dresden, 01307, Germany

Location

Related Publications (3)

  • 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.

    PMID: 16459089BACKGROUND

  • 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.

    PMID: 17339580BACKGROUND

  • 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.

    PMID: 12843342BACKGROUND

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Imanuel Dzialowski, MD

    University of Dresden, Dept of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

May 14, 2009

Record last verified: 2009-01

Locations

DE(1)