International T1 Multicenter Outcome Study

Active, not recruiting

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

• Registration Number: NCT03749343
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2030-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	5 year	number of deaths

Secondary Outcome Measures

Name	Time	Method
Rate of death due to to cardiovascular causes	5 year	Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Rate of Arrhythmia	5 year	Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Rate of Heart Failure events	5 year	Number of participants with events including death and Hospitalisation due to Heart Failure

Trial Locations

Locations (3)

Kerckhoff Hospital; 🇩🇪 Bad Nauheim, Hessen, Germany

Institute for experimental and translational cardiovascular imaging; 🇩🇪 Frankfurt Am Main, Hessen, Germany

University Hospital Mainz; 🇩🇪 Mainz, Hessen, Germany