The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography
DUST
2 other identifiers
observational
1,500
1 country
14
Brief Summary
Less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (IVT) as most present later than the accepted 3 hour time window. Intra-arterial thrombolysis (IAT) is possible 3-6 hours post ictus, but is infrequently used. Mechanical thrombectomy (MT) with a MERCI device is a new intervention possibility but lacks large randomized studies. Although it is desirable to treat more stroke patients, clinical information and plain CT alone are insufficient to discriminate which patients are most likely to benefit or be harmed from treatment. Advanced imaging techniques can help predict patient outcome and provide the necessary information to weigh expected benefit against associated risk of treatment. Visualizing the penumbra, the hypoperfused tissue at risk of infarction around the irreversible infarct core, is one way of identifying patients most likely to benefit from intervention. Magnetic resonance imaging (MRI) based selection of patients with sufficient penumbra for thrombolysis is possible, however, MR has less 24-hour availability than CT in the acute setting. Plain CT is mostly used to exclude intracerebral hemorrhage, and can easily be extended with CT perfusion (CTP) and CT angiography (CTA). CTP compares well to MRI for imaging penumbra and infarct core, and it is faster and more feasible than MRI. Other image findings such as infarct core size and leakage of the blood-brain-barrier (permeability) on CTP, and site and extent of the occlusion and collateral circulation on CTA also influence stroke outcome but have not been combined in one study to assess their combined predictive value. Hypothesis: The investigators hypothesize that combined CTP and CTA parameters can predict patient outcome in acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedJune 5, 2012
June 1, 2012
4.6 years
April 10, 2009
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale
90 days
Secondary Outcomes (4)
Final infarct size on CT
Day 3
Recanalization (CTA)
Day 3
Symptomatic hemorrhage
Day 3
Asymptomatic hemorrhage
Day 3
Study Arms (1)
Acute stroke
Patients over 18 years of age with acute stroke symptoms of less then 9 hours duration and no hemorrhage on non-contrast CT.
Interventions
Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).
Eligibility Criteria
Patients 18 years or older with acute stroke symptoms who present in the hospital within 9 hours of onset of symptoms.
You may qualify if:
- Acute neurological deficit caused by cerebral ischaemia
- Admission \< 9 hours after onset of neurological deficit
- NIH Stroke Scale (NIHSS) of at least 2
- No absolute contraindications against intravenous contrast
- Informed consent from patient or family after admission scan
- Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours
You may not qualify if:
- Neurological deficit caused by another diagnosis than cerebral ischaemia (such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor)
- Patients with known contrast allergy or kidney failure
- Patients with the known combination of renal insufficiency and heart failure (New York Heart Association (NYHA) IV) will be excluded for the CTP and CTA scan at 3 days; they will have a non-contrast CT (NCCT) at that time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Dutch Heart Foundationcollaborator
Study Sites (14)
Academic Medical Center
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands
Gelre Hospitals
Apeldoorn, Netherlands
Alysis Zorggroep
Arnhem, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Leiden University Medical Center
Leiden, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
St. Franciscus Gasthuis
Rotterdam, Netherlands
Medical Center Haaglanden, location Westeinde
The Hague, Netherlands
St. Elisabeth Hospital
Tilburg, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Related Publications (7)
Dankbaar JW, Horsch AD, van den Hoven AF, Kappelle LJ, van der Schaaf IC, van Seeters T, Velthuis BK; DUST Investigators. Prediction of Clinical Outcome After Acute Ischemic Stroke: The Value of Repeated Noncontrast Computed Tomography, Computed Tomographic Angiography, and Computed Tomographic Perfusion. Stroke. 2017 Sep;48(9):2593-2596. doi: 10.1161/STROKEAHA.117.017835. Epub 2017 Jul 17.
PMID: 28716981DERIVEDLuitse MJ, Velthuis BK, Kappelle LJ, van der Graaf Y, Biessels GJ; DUST Study Group. Chronic hyperglycemia is related to poor functional outcome after acute ischemic stroke. Int J Stroke. 2017 Feb;12(2):180-186. doi: 10.1177/1747493016676619. Epub 2016 Oct 26.
PMID: 27784821DERIVEDvan den Wijngaard IR, Wermer MJ, Boiten J, Algra A, Holswilder G, Meijer FJ, Dippel DW, Velthuis BK, Majoie CB, van Walderveen MA. Cortical Venous Filling on Dynamic Computed Tomographic Angiography: A Novel Predictor of Clinical Outcome in Patients With Acute Middle Cerebral Artery Stroke. Stroke. 2016 Mar;47(3):762-7. doi: 10.1161/STROKEAHA.115.012279. Epub 2016 Jan 26.
PMID: 26814234DERIVEDvan den Wijngaard IR, Boiten J, Holswilder G, Algra A, Dippel DW, Velthuis BK, Wermer MJ, van Walderveen MA. Impact of Collateral Status Evaluated by Dynamic Computed Tomographic Angiography on Clinical Outcome in Patients With Ischemic Stroke. Stroke. 2015 Dec;46(12):3398-404. doi: 10.1161/STROKEAHA.115.010354. Epub 2015 Nov 5.
PMID: 26542691DERIVEDBennink E, Oosterbroek J, Horsch AD, Dankbaar JW, Velthuis BK, Viergever MA, de Jong HW. Influence of Thin Slice Reconstruction on CT Brain Perfusion Analysis. PLoS One. 2015 Sep 11;10(9):e0137766. doi: 10.1371/journal.pone.0137766. eCollection 2015.
PMID: 26361391DERIVEDLuitse MJ, Velthuis BK, Dauwan M, Dankbaar JW, Biessels GJ, Kappelle LJ; Dutch Acute Stroke Study Group. Residual high-grade stenosis after recanalization of extracranial carotid occlusion in acute ischemic stroke. Stroke. 2015 Jan;46(1):12-5. doi: 10.1161/STROKEAHA.114.007169. Epub 2014 Dec 9.
PMID: 25492908DERIVEDFahmi F, Marquering HA, Borst J, Streekstra GJ, Beenen LF, Niesten JM, Velthuis BK, Majoie CB, vanBavel E; DUST study. 3D movement correction of CT brain perfusion image data of patients with acute ischemic stroke. Neuroradiology. 2014 Jun;56(6):445-52. doi: 10.1007/s00234-014-1358-7. Epub 2014 Apr 9.
PMID: 24715201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2013
Last Updated
June 5, 2012
Record last verified: 2012-06