Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by UMC Utrecht.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00880113
First received: April 10, 2009
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Acute Stroke
Procedure: Non-contrast CT, CT-perfusion and CT-angiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With CT-perfusion and CT-angiography

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final infarct size on CT [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Recanalization (CTA) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Symptomatic hemorrhage [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Asymptomatic hemorrhage [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: May 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880113

Locations
Netherlands
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
Sponsors and Collaborators
UMC Utrecht
Dutch Heart Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: B.K. Velthuis, University Medical Center Utrecht
ClinicalTrials.gov Identifier: NCT00880113     History of Changes
Other Study ID Numbers: 2008T034  NL25625.041.08 
Study First Received: April 10, 2009
Last Updated: June 4, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
CT-perfusion
CT-angiography

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

ClinicalTrials.gov processed this record on December 09, 2016