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

June 4, 2012 updated by: UMC Utrecht

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Final infarct size on CT
Time Frame: Day 3
Day 3
Recanalization (CTA)
Time Frame: Day 3
Day 3
Symptomatic hemorrhage
Time Frame: Day 3
Day 3
Asymptomatic hemorrhage
Time Frame: Day 3
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Dutch Heart Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 4, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008T034
  • NL25625.041.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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