The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography (DUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00880113
Recruitment Status : Unknown
Verified June 2012 by UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : April 13, 2009
Last Update Posted : June 5, 2012
Dutch Heart Foundation
Information provided by:
UMC Utrecht

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.


The investigators hypothesize that combined CTP and CTA parameters can predict patient outcome in acute ischemic stroke.

Condition or disease Intervention/treatment
Acute Stroke Procedure: Non-contrast CT, CT-perfusion and CT-angiography

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With CT-perfusion and CT-angiography
Study Start Date : May 2009
Estimated Primary Completion Date : December 2013

Group/Cohort Intervention/treatment
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.
Procedure: Non-contrast CT, CT-perfusion and CT-angiography
Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).

Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Final infarct size on CT [ Time Frame: Day 3 ]
  2. Recanalization (CTA) [ Time Frame: Day 3 ]
  3. Symptomatic hemorrhage [ Time Frame: Day 3 ]
  4. Asymptomatic hemorrhage [ Time Frame: Day 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00880113

Contact: Tom van Seeters, MD 0031887553252

Academic Medical Center Recruiting
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG) Recruiting
Amsterdam, Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands
Gelre Hospitals Recruiting
Apeldoorn, Netherlands
Alysis Zorggroep Recruiting
Arnhem, Netherlands
Catharina Hospital Recruiting
Eindhoven, Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands
UMC St. Radboud Recruiting
Nijmegen, Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
St. Franciscus Gasthuis Recruiting
Rotterdam, Netherlands
Medical Center Haaglanden, location Westeinde Recruiting
The Hague, Netherlands
St. Elisabeth Hospital Recruiting
Tilburg, Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Dutch Heart Foundation

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: B.K. Velthuis, University Medical Center Utrecht Identifier: NCT00880113     History of Changes
Other Study ID Numbers: 2008T034
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by UMC Utrecht:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases