International T1 Multicenter Outcome Study (T1Outcome-DE)

Johann Wolfgang Goethe University Hospital

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases; Coronary Artery Disease; Heart Failure; Cardiomyopathies; Inflammatory Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03749343

T1 Outcome 1/16gA

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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