CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00463281

Acronym

CT-DEFINE

Enrollment

100

Registered

2007-04-20

Start date

2007-01-31

Completion date

2009-01-31

Last updated

2009-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, ischemic, computed tomography, thrombolysis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
modified Rankin Scale scores 0-2	90 days

Countries

Germany

Outcome results