ISRCTN54540667已完成不适用
Paramedic Initiated Lisinopril For Acute Stroke: a pilot, double blinded, randomised, placebo controlled trial
ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 60 人开始时间: 2011年1月10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
- 60
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. Adults greater than or equal to 40 years old
- •2. New unilateral arm weakness thought to be due to acute stroke within 3 hours of symptom onset
- •3. Hypertension as defined by systolic blood pressure (SBP) greater than 160 mmHg on two consecutive seated or lying readings taken 5 - 10 minutes apart
- •4. Conscious (eyes open spontaneously i.e. 'A' on Alert, Voice, Pain, Unresponsive [AVPU] scale)
- •5. Patient being transported to a PIL-FAST trial site (i.e. Royal Victoria Infirmary, North Tyneside General Hospital and Wansbeck General Hospital)
- •6. Verbal consent obtained from participant or next of kin
排除标准
- •1. Aged less than 40 years
- •2. Females who are pregnant, lactating or at risk of pregnancy (i.e. who are not surgically sterile or at least 1 year post last menstrual period). Females less than 56 years of age consented by a relative will be excluded as menstrual history may be unknown.
- •3. Any presentation of suspected stroke without unilateral arm weakness
- •4. Cannot establish that stroke onset time (i.e. when patient was last seen well without s symptoms) was within the last 3 hours
- •5. SBP less than 160 mmHg
- •6. Reduced level of consciousness (below 'A' on AVPU scale)
- •7. Patient not being transported to PIL-FAST trial site
- •8. Absence of participant or next of kin consent
- •9. Known to be taking ACE-inhibitor or Angiotensin II Receptor Blocker medication already
- •10. Known sensitivity to lisinopril or other ACE-inhibitor medication
- •11. Pulse greater than 120 beats per minute
- •12. Seizure activity in this illness episode (witnessed or history)
- •13. Hypoglycaemia (blood glucose less than 3.5 mmol/l)
- •14. Cannot walk independently prior to stroke (walking stick/frame is allowed)
- •15. Obvious understanding or memory problems when next of kin is absent
- •16. Significant head trauma or brain surgery in the last 3 months
- •17. Known renal failure
- •18. Known liver failure (or currently jaundiced)
- •19. Uncontrolled heart failure (breathlessness at rest)
- •20. Receiving palliative care for known malignancy
- •21. Currently enrolled in a clinical trial assessing a study drug
研究者
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