跳至主要内容
临床试验/NCT03749343
NCT03749343进行中(未招募)不适用

International T1 Multicenter Outcome Study (the German Chapter)

Johann Wolfgang Goethe University Hospital3 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
8,000
试验地点
3
主要终点
Survival

研究概览

简要总结

Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable) myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE) as the tool for regional myocardial disease. A handful of studies, three single centre study of a single T1 index with outcomes and one multicentre study for all indices reported strong associations with all cause mortality and heart failure. These studies were based on a single-vendor platform and were using a single sequence. The main unknowns pertaining the successful translation of this technique and the transferability of the methodology beyond a single centre and lack of outcome evidence from broad and large populations. In this study, we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and disease, and the prognostic relevance of T1 mapping measurements by associations with outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which remains active for follow-up, but is currently no longer recruiting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (>18 years of age)
  • Able to provide informed consent
  • Clinically indicated cardiac magnetic resonance imaging study

排除标准

  • contraindications for clinical cardiac magnetic resonance imaging due to MR unsafe devices or objects

结局指标

主要结局

Survival

时间窗: 5 year

number of deaths

Survival

时间窗: 1 year

number of deaths

次要结局

  • Rate of death due to to cardiovascular causes(5 year)
  • Rate of Arrhythmia(5 year)
  • Rate of Heart Failure events(5 year)
  • Rate of Heart Failure events(1 year)
  • Rate of Arrhythmia(1 year)
  • Rate of death due to to cardiovascular causes(1 year)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Puentmann

Principal Investigator, Clinical professor

Johann Wolfgang Goethe University Hospital

研究点 (3)

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