The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography
Recruitment status was Recruiting
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.
The investigators hypothesize that combined CTP and CTA parameters can predict patient outcome in acute ischemic stroke.
|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|
- Modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880113
|Contact: Tom van Seeters, MD||0031887553252||T.vanSeeters@umcutrecht.nl|
|Onze Lieve Vrouwe Gasthuis (OLVG)||Recruiting|
|Academic Medical Center||Recruiting|
|VU Medical Center||Recruiting|
|Leiden University Medical Center||Recruiting|
|St. Antonius Hospital||Recruiting|
|UMC St. Radboud||Recruiting|
|Erasmus Medical Center||Recruiting|
|St. Franciscus Gasthuis||Recruiting|
|Medical Center Haaglanden, location Westeinde||Recruiting|
|The Hague, Netherlands|
|St. Elisabeth Hospital||Recruiting|
|University Medical Center Utrecht||Recruiting|