EUCTR2012-001582-33-DE进行中（未招募）不适用
Intraindividual cross-over comparison of Gadobutrol and Gadoterate enhanced combined DSC-MR-Perfusion and MR-Angiography in patients with cerebrovascular disease - Erlangen Perfusion Stroke
niversity Hospital Erlangen0 个研究点开始时间: 2012年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. adult patients, 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 injection
- •4. willing to undergo and comply with all study procedures
- •5. written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 patients on hemodialysis. In patients 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 renal or liver transplant, including patients with scheduled liver transplant 4. with known allergy or any contraindication to Gadobutrol or Gadoterate.
- •5. presenting with a history of anaphylactoid or anaphylactic reaction to any drug or contrast agent.
- •6. with high grade cardiac arrhythmia
- •7. not being able to remain lying down for at least 30-45 min (e.g., patients with unstable angina, dyspnoea at rest, severe pain at rest, severe back pain)
- •8. having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
- •9. with a contraindication for MRI (pacemaker, magnetic clips, severe claustrophobia etc.)
- •10. being clinically unstable or requiring emergency treatment
- •11. with close affiliation with the investigational site; e.g. a close relative of the investigator
- •12. who have received any investigational drug within 7 days prior to entering this study
- •13. who have received any contrast agent within 24 hours prior to entering this study
- •14. who have previously entered this study
- •15. participating in another clinical trial
- •16. having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
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