International T1 Multicenter Outcome Study

Study Overview
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Brief Summary
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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.

Official Title
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International T1 Multicenter Outcome Study (the German Chapter)

Conditions
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Heart Failure, Cardiomyopathies, Inflammatory Disease, Coronary Artery Disease, Chronic Kidney Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years of age) Able to provide informed consent Clinically indicated cardiac magnetic resonance imaging study Exclusion Criteria: contraindications for clinical cardiac magnetic resonance imaging due to MR unsafe devices or objects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | number of deaths | 1 year | 
| Survival | number of deaths | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Heart Failure events | Number of participants with events including death and Hospitalisation due to Heart Failure | 1 year | 
| Rate of Heart Failure events | Number of participants with events including death and Hospitalisation due to Heart Failure | 5 year | 
| Rate of Arrhythmia | Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT | 1 year | 
| Rate of Arrhythmia | Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT | 5 year | 
| Rate of death due to to cardiovascular causes | Number of participants with death due to myocardial infarction, heart failure, arrhythmia | 1 year | 
| Rate of death due to to cardiovascular causes | Number of participants with death due to myocardial infarction, heart failure, arrhythmia | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1 mapping, native T1, native T2, accuracy, prognosis