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

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT00880113

Collaborator

Dutch Heart Foundation (Other)

1,500

Enrollment

Locations

107.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Procedure: Non-contrast CT, CT-perfusion and CT-angiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale [90 days]

Secondary Outcome Measures

Final infarct size on CT [Day 3]
Recanalization (CTA) [Day 3]
Symptomatic hemorrhage [Day 3]
Asymptomatic hemorrhage [Day 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Academic Medical Center	Amsterdam	Netherlands
2	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam	Netherlands
3	VU Medical Center	Amsterdam	Netherlands
4	Gelre Hospitals	Apeldoorn	Netherlands
5	Alysis Zorggroep	Arnhem	Netherlands
6	Catharina Hospital	Eindhoven	Netherlands
7	Leiden University Medical Center	Leiden	Netherlands
8	St. Antonius Hospital	Nieuwegein	Netherlands
9	UMC St. Radboud	Nijmegen	Netherlands
10	Erasmus Medical Center	Rotterdam	Netherlands
11	St. Franciscus Gasthuis	Rotterdam	Netherlands
12	Medical Center Haaglanden, location Westeinde	The Hague	Netherlands
13	St. Elisabeth Hospital	Tilburg	Netherlands
14	University Medical Center Utrecht	Utrecht	Netherlands

Sponsors and Collaborators

UMC Utrecht
Dutch Heart Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00880113

Other Study ID Numbers:

2008T034
NL25625.041.08

First Posted:

Apr 13, 2009

Last Update Posted:

Jun 5, 2012

Last Verified:

Jun 1, 2012

Keywords provided by , ,

CT-perfusion

CT-angiography

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 5, 2012