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Sponsors and Collaborators: |
UMC Utrecht Dutch Heart Foundation |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00880113 |
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 |
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Acute Stroke |
Procedure: Non-contrast CT, CT-perfusion and CT-angiography |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With CT-Perfusion and CT-Angiography |
Estimated Enrollment: | 1500 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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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.
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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).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients 18 years or older with acute stroke symptoms who present in the hospital within 9 hours of onset of symptoms.
Inclusion Criteria:
Exclusion Criteria:
Contact: Tom van Seeters, MD | 0031887553252 | T.vanSeeters@umcutrecht.nl |
Netherlands | |
University Medical Center Utrecht | |
Utrecht, Netherlands | |
Alysis Zorggroep | |
Arnhem, Netherlands | |
Academic Medical Center | |
Amsterdam, Netherlands | |
VU Medical Center | |
Amsterdam, Netherlands | |
St. Franciscus Gasthuis | |
Rotterdam, Netherlands | |
Catharina Hospital | |
Eindhoven, Netherlands | |
St. Elisabeth Hospital | |
Tilburg, Netherlands | |
Medical Center Haaglanden, location Westeinde | |
The Hague, Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands |
Responsible Party: | University Medical Center Utrecht ( B.K. Velthuis ) |
Study ID Numbers: | 2008T034, NL25625.041.08 |
Study First Received: | April 10, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880113 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
CT-perfusion CT-angiography |
Cerebral Infarction Stroke Vascular Diseases |
Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders |