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International T1 Multicenter Outcome Study

International T1 Multicenter Outcome Study (the German Chapter)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03749343
Acronym
T1Outcome-DE
Enrollment
8000
Registered
2018-11-21
Start date
2016-03-01
Completion date
2030-02-28
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

T1 mapping, native T1, native T2, accuracy, prognosis

Brief 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.

Interventions

None listed

Sponsors

Kerckhoff Klinik
CollaboratorOTHER
Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Adults (\>18 years of age) 2. Able to provide informed consent 3. Clinically indicated cardiac magnetic resonance imaging study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Survival1 yearnumber of deaths

Secondary

MeasureTime frameDescription
Rate of Heart Failure events1 yearNumber of participants with events including death and Hospitalisation due to Heart Failure
Rate of Arrhythmia1 yearNumber of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Rate of death due to to cardiovascular causes1 yearNumber of participants with death due to myocardial infarction, heart failure, arrhythmia

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026