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

• Conditions: Acute Stroke
• Interventions: Procedure: Non-contrast CT, CT-perfusion and CT-angiography

• Registration Number: NCT00880113
• Lead Sponsor: 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.

Hypothesis:

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Study Start: 2009-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute stroke	Non-contrast CT, CT-perfusion and CT-angiography	Patients over 18 years of age with acute stroke symptoms of less then 9 hours duration and no hemorrhage on non-contrast CT.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	90 days

Secondary Outcome Measures

Name	Time	Method
Final infarct size on CT	Day 3
Recanalization (CTA)	Day 3
Symptomatic hemorrhage	Day 3
Asymptomatic hemorrhage	Day 3

Trial Locations

Locations (14)

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands

St. Franciscus Gasthuis; 🇳🇱 Rotterdam, Netherlands

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis (OLVG); 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Alysis Zorggroep; 🇳🇱 Arnhem, Netherlands

Gelre Hospitals; 🇳🇱 Apeldoorn, Netherlands

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

St. Elisabeth Hospital; 🇳🇱 Tilburg, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Medical Center Haaglanden, location Westeinde; 🇳🇱 The Hague, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands