International T1 Multicenter Outcome Study (the German Chapter)
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
- 否
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
Valentina Puentmann
Principal Investigator, Clinical professor
Johann Wolfgang Goethe University Hospital
