跳至主要内容
临床试验/EUCTR2009-017739-17-DE
EUCTR2009-017739-17-DE进行中(未招募)1 期

Assessment of myocardial viability in MRI: Comparison of Late Gadolinium Enhancement with Gadovist vs. Magnevist vs. Dotarem - Cardiac LGE

Charité0 个研究点目标入组 40 人开始时间: 2010年1月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
40

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 years and older
  • 2.History of chronic myocardial infarction (echocardiography or ECG)
  • 3.Willing to undergo and to comply with all study procedures
  • 4.Written informed consent, self-signed and dated, voluntarily given
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.who are female of childbearing potential or in nursery
  • 2.with moderate impaired renal function (GFR calculated with MDRD formula =60 mL/min/1.72m2). Serum creatinine values must not be older than 12 weeks
  • 3.with renal transplant, including patients with scheduled renal transplantation
  • 4.with a contraindication to MRI (e.g. pacemaker, clips, severe claustrophobia)
  • 5.with known allergy or any contraindication to Gadovist, Magnevist and/or Dotarem
  • 6.presenting with a history of anaphylactoid or anaphylactic reaction to any of the ingredients of the study drugs.
  • 7.having any physical or mental status interfering with the informed consent procedure including self-signed informed consent
  • 8.being unstable or requiring emergency treatment
  • 9.with close affiliation with the investigational site; e.g. a close relative of the investigator
  • 10.who have received any contrast agent within 24 hours prior to entering this study
  • 11.who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the study procedures
  • 12.having an underlying disease or concomitant medication which may interfere with efficacy evaluation.
  • 13.participating in another clinical trial
  • 14.who have previously entered this study
  • 15. with severe cardiovascular disease (e.g. congenital or family history of QT syndrome)
  • 16. who are for legal or regulatory reasons hospitilized in an institution

研究者

发起方
Charité

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