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

Acute Stroke Clinical Trial

— DUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00880113
• Other study ID #: 2008T034
• Secondary ID: NL25625.041.08
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2009
• Last updated: June 4, 2012
• Start date: May 2009

Study information

• Verified date: June 2012
• Source: UMC Utrecht
• Contact: Tom van Seeters, MD
• Phone: 0031887553252
• Email: T.vanSeeters[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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).

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale		90 days	No
Secondary	Final infarct size on CT		Day 3	No
Secondary	Recanalization (CTA)		Day 3	No
Secondary	Symptomatic hemorrhage		Day 3	No
Secondary	Asymptomatic hemorrhage		Day 3	No