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临床试验/NCT00880113
NCT00880113Unknown不适用

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

UMC Utrecht14 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
UMC Utrecht
入组人数
1,500
试验地点
14
主要终点
Modified Rankin Scale

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Modified Rankin Scale

时间窗: 90 days

次要结局

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

研究者

发起方
UMC Utrecht
申办方类型
Other

研究点 (14)

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