NCT03749343

International T1 Multicenter Outcome Study

International T1 Multicenter Outcome Study (the German Chapter)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Heart Failure
• Cardiomyopathies
• Inflammatory Disease
• Coronary Artery Disease
• Chronic Kidney Diseases

Timeline

• Start date: 2016-03-01
• Primary completion: 2030-02-28
• Completion: 2030-02-28
• First posted: 2018-11-21
• Last updated: 2026-01-06

Locations

2 sites across 1 country: Germany