ISRCTN69163448已完成不适用
Imaging-based Thrombolysis Trial in Acute Ischemic Stroke
Ministry of Science and Technology of the People's Republic of China (China)0 个研究点目标入组 80 人开始时间: 2005年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18-75 years
- •2. Clinical signs consistent with the diagnosis of ischemic stroke
- •3. Treatment onset within 3-9 hours after stroke onset
- •4. No prior neurologic event that would obscure the interpretation of the signal
- •and current presenting neurologic deficits (modified Rankin scale [mRS] =1)
- •5. National Institutes of Health-Stroke-Scale (NIHSS) score >4 and at least moderate limb weakness
- •6. MRI screening to be started within 7.5 hours after stroke onset
- •7. Perfusion abnormality of >2 cm in diameter involving hemispheric gray matter
- •8. Perfusion/diffusion mismatch of =20
- •9. Magnetic resonance angiography (MRA) shows that TICI grade is 0 or 1
排除标准
- •1. Patients not eligible to receive trial treatment within 30-60 min after completion of MRI1
- •3. Stroke symptoms are rapidly improving by the time of randomization
- •4. Major stroke symptoms (>25 to 30 on the NIHSS)
- •5. History of stroke within the previous 6 weeks
- •6. Seizure at the onset of stroke
- •7. Stroke due to a neurointerventional procedure for treatment of a cerebral aneurysm and/or cerebral arteriovenous malformation (stroke due to diagnostic cerebral angiography or cardiac catheterization might be treated)
- •8. Clinical presentation suggestive of subarachnoid hemorrhage, even when the MRI is normal
- •9. History of intracerebral hemorrhage (ICH) at any time, neoplasm, subarachnoid hemorrhage (SAH), arteriovenous malformation (AVM) or aneurysm
- •10. Presumed septic embolus
- •11. Presumed pericarditis related to recent acute myocardial infarction
- •12. Recent (within 10 to 30 days) surgery, biopsy of a parenchymal organ, or lumbar puncture
- •13. Recent (within 10 to 30 days) trauma (including head trauma), with internal injuries or ulcerative wounds
- •14. Known active inflammatory bowel disease, ulcerative colitis, or diverticular disease
- •15. Any active or recent (within 10 to 30 days) hemorrhage
- •16. Known hereditary or acquired hemorrhagic diathesis. Baseline laboratory values that reveal platelets are <100 000/µl, hematocrit or platelet cell volume <25 volume %, or oral anticoagulant therapy with an international normalized ratio >1.7.
- •17. Pregnancy, lactation, or parturition within the previous 30 days
- •18. Known serious sensitivity to radiographic contrast agents
- •19. Other serious, advanced, or terminal illness such that life expectancy is <1 year
- •20. Any other condition that the physician believes would pose a significant hazard to the patient if fibrinolytic therapy were initiated (e.g. amyloid angiopathy)
- •21. Uncompensated hypertension at study entry or hypertension requiring aggressive treatment to reduce blood pressure to nonhypertensive limits. Uncompensated hypertension is defined as systolic blood pressure >180 mmHg or diastolic blood pressure =105 mmHg on 3 repeated measures at least 10 minutes apart. Aggressive treatment is defined as the need for a continuous, parenteral antihypertensive, such as a nitroprusside drip, or the need to administer >3 doses of a parenteral antihypertensive, such as labetalol or Urapidil.
- •22. Evidence of ICH or SAH
- •23. DWI abnormality involving >1/3 of middle cerebral artery (MCA) territory
- •24. No perfusion deficit
- •25. Any intracranial pathology interfering with the assessment of diffusion and
- •perfusion abnormalities
- •26. Contraindications to MRI
研究者
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