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
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