DRKS00009914已完成4 期
Intraindividual cross-over comparison of Gadobutroland Gadoterate enhanced combined DSC-MR-Perfusion and MRAngiographyin patients with cerebrovascular disease - SAPP STROKE
niversitätsklinikum Erlangen0 个研究点目标入组 73 人开始时间: 2016年1月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. adult subjects, age 18-85 years
- •2. with clinically suspected or definite ischemic stroke or an intracranial stenosis
- •(> 50% degree) or extracranial stenosis of the internal carotid artery (> 70%)
- •3. clinically indicated initial and follow-up MR examinations of the brain with contrast
- •4. willing to undergo and comply with all study procedures
- •5. written informed consent
排除标准
- •1. who are in pregnancy or nursery. In women with child bearing potential a pregnancy test
- •must be performed directly before each MR examination in order to safely exclude
- •pregnancy. The manufacturer’s instructions for performing the urinary pregnancy test are to
- •be followed.
- •2. with impaired renal function of CKD stadium 3 and higher (i.e. creatinine clearance < 60
- •ml/min/1.73m² (Cockroft-Gault formula) or subjects on hemodialysis. In subjects with
- •known renal impairment, clearance will be calculated based on serum creatinine level
- •using the Cockroft-Gault formula. Calculation of the clearance must be done before begin
- •of study. Serum creatinine value must not be older than one week (7 days) before study
- •related contrast injection.
- •3. with severe hepatic impairment (SGPT > 2 x upper limit value)
- •4. with renal or liver transplant, including subjects with scheduled liver transplant
- •5. with known allergy or any contraindication to Gadobutrol or Gadoterate.
- •6. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast
- •7. with high grade cardiac arrhythmia
- •8. not being able to remain lying down for at least 30-45 min (e.g., subjects with unstable
- •angina, dyspnoea at rest, severe pain at rest, severe back pain)
- •9. having any physical or mental status that interferes with the informed consent procedure
- •including self-signed consent.
- •10. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.)
- •11. being clinically unstable or requiring emergency treatment
- •12. with close affiliation with the investigational site; e.g. a close relative of the investigator
- •13. who have received any investigational drug within 7 days prior to entering this study
- •14. who have received any contrast media within 24 hours prior to entering this study
- •15. who have previously entered this study
- •16. participating in another clinical trial
- •17. having an underlying disease or concomitant medication which may interfere with
- •efficacy evaluation
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