AzTrials
AzTrials

Acute StrokeDUSTNCT00880113

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

An observational study of Acute Stroke, run by UMC Utrecht at 14 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Stroke
What is being tested?
Non-contrast CT, CT-perfusion and CT-angiography
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
14 sitesNetherlands
Study dates
May 2009to Dec 2013
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: Patients 18 years or older with acute stroke symptoms who present in the hospital within 9 hours of onset of symptoms.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

Tom van Seeters, MD contact

0031887553252

T.vanSeeters@umcutrecht.nl

14 sites in 1 country

Netherlands14 sites, 14 recruiting

  • Academic Medical Center

    Amsterdam

    Recruiting

  • Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam

    Recruiting

  • VU Medical Center

    Amsterdam

    Recruiting

  • Gelre Hospitals

    Apeldoorn

    Recruiting

  • Alysis Zorggroep

    Arnhem

    Recruiting

  • Catharina Hospital

    Eindhoven

    Recruiting

  • Leiden University Medical Center

    Leiden

    Recruiting

  • St. Antonius Hospital

    Nieuwegein

    Recruiting

  • UMC St. Radboud

    Nijmegen

    Recruiting

  • Erasmus Medical Center

    Rotterdam

    Recruiting

  • St. Franciscus Gasthuis

    Rotterdam

    Recruiting

  • Medical Center Haaglanden, location Westeinde

    The Hague

    Recruiting

  • St. Elisabeth Hospital

    Tilburg

    Recruiting

  • University Medical Center Utrecht

    Utrecht

    Recruiting

Other trials in Netherlands

About this study

Official title: The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With CT-perfusion and CT-angiography

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.

Conditions
Acute Stroke
Being tested
Non-contrast CT, CT-perfusion and CT-angiography
Keywords
CT-perfusion, CT-angiography
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-contrast CT, CT-perfusion and CT-angiographyProcedure or surgery

    Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).

Study groups in NCT00880113
Study groupRoleWhat they receive
Acute strokePatients over 18 years of age with acute stroke symptoms of less then 9 hours duration and no hemorrhage on non-contrast CT.
Receives: Procedure: Non-contrast CT, CT-perfusion and CT-angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale

    Measured: 90 days

Secondary outcomes (4)

  1. Final infarct size on CT

    Measured: Day 3

  2. Recanalization (CTA)

    Measured: Day 3

  3. Symptomatic hemorrhage

    Measured: Day 3

  4. Asymptomatic hemorrhage

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2013 (estimated)

Resources

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
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880113
Sponsor's protocol ID
2008T034
Other IDs
NL25625.041.08
Acronym
DUST
Status last verified
Jun 2012
First submitted
10 Apr 2009
Last updated
5 Jun 2012
Results posted
No

Publications

  • 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.

    PubMed 28716981

  • 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.

    PubMed 27784821

  • 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.

    PubMed 26814234

  • 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.

    PubMed 26542691

  • 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.

    PubMed 26361391

  • 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.

    PubMed 25492908

  • 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.

    PubMed 24715201

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Stroke, run by UMC Utrecht at 14 sites in Netherlands.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tom van Seeters, MD (0031887553252, T.vanSeeters@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (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 NCT00880113, which also lists 7 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 5 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in