StrokeCT-DEFINENCT00463281
CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis
An observational study of Stroke, run by Technische Universität Dresden at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients presenting within 12 hrs from symptom onset
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis
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.
- Conditions
- Stroke
- Keywords
- stroke, ischemic, computed tomography, thrombolysis
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale scores 0-2
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Imanuel Dzialowski, MD, Principal investigator, University of Dresden, Dept of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463281
- Sponsor's protocol ID
- 23211204
- Acronym
- CT-DEFINE
- Status last verified
- Jan 2009
- First submitted
- 19 Apr 2007
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16459089Parsons 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.
PubMed 17339580Hill 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.
PubMed 12843342
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis
- ClinicalTrials.gov ID
- NCT00463281
- Acronym / sponsor ID
- CT-DEFINE / 23211204
- Conditions
- Stroke
- Keywords
- stroke, ischemic, computed tomography, thrombolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients presenting within 12 hrs from symptom onset
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Rankin Scale scores 0-2
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
- Background: PubMed 16459089Pepper 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.
- Background: PubMed 17339580Parsons 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.
- Background: PubMed 12843342Hill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imanuel Dzialowski, MD principal investigator
University of Dresden, Dept of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale scores 0-2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463281, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2009.