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NCT Number: NCT03749343

International T1 Multicenter Outcome Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Arterial Occlusive Diseases Arteriosclerosis Cardiomyopathies Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Coronary Artery Disease Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Inflammatory Disease Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kerckhoff Hospital, Bad Nauheim, Hesse, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: 1 year

    number of deaths

  2. Survival

    Time frame: 5 year

    number of deaths

Secondary outcomes

  1. Rate of Heart Failure events

    Time frame: 1 year

    Number of participants with events including death and Hospitalisation due to Heart Failure

  2. Rate of Heart Failure events

    Time frame: 5 year

    Number of participants with events including death and Hospitalisation due to Heart Failure

  3. Rate of Arrhythmia

    Time frame: 1 year

    Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT

  4. Rate of Arrhythmia

    Time frame: 5 year

    Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT

  5. Rate of death due to to cardiovascular causes

    Time frame: 1 year

    Number of participants with death due to myocardial infarction, heart failure, arrhythmia

  6. Rate of death due to to cardiovascular causes

    Time frame: 5 year

    Number of participants with death due to myocardial infarction, heart failure, arrhythmia

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Kerckhoff Klinik

Registry information

Official study title

International T1 Multicenter Outcome Study (the German Chapter)

Acronym: T1Outcome-DE

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Nov 21, 2018
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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