Clinical trial NCT00880113: The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography
Official title: The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With CT-perfusion and CT-angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Keywords: CT-perfusion
CT-angiography
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2009-04-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years or older with acute stroke symptoms who present in the hospital within 9 hours of onset of symptoms.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 90 days
Secondary outcomes:
measure: Final infarct size on CT
timeFrame: Day 3
measure: Recanalization (CTA)
timeFrame: Day 3
measure: Symptomatic hemorrhage
timeFrame: Day 3
measure: Asymptomatic hemorrhage
timeFrame: Day 3
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden, location Westeinde
city: Tilburg
country: Netherlands
facility: St. Elisabeth Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: 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.
citation: Luitse 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.
citation: van 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.
citation: van 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.
citation: Bennink 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.
citation: Luitse 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.
citation: Fahmi 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.