International T1 Multicenter Outcome Study

Coronary Artery Disease Clinical Trial

— T1Outcome-DE  

Official title:

International T1 Multicenter Outcome Study (the German Chapter)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749343
• Other study ID #: T1 Outcome 1/16gA
• Status: Recruiting
• Start date: March 1, 2016
• Est. completion date: February 28, 2030

Study information

• Verified date: July 2023
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Valentina O Puentmann, MD, PhD
• Email: cvi-research[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: February 28, 2030
• Est. primary completion date: February 28, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Kidney Diseases
• Coronary Artery Disease
• Heart Failure
• Inflammatory Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	Kerckhoff Hospital	Bad Nauheim	Hessen
Germany	Institute for experimental and translational cardiovascular imaging	Frankfurt Am Main	Hessen
Germany	University Hospital Mainz	Mainz	Hessen

Sponsors (3)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Johannes Gutenberg University Mainz, Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and — View Citation

Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Rolf A, Zitzmann S, Peker E, D'Angelo T, Pathan F, Elen, Valbuena S, Hinojar R, Arendt C, Narula J, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. Native T1 a — View Citation

Winau L, Hinojar Baydes R, Braner A, Drott U, Burkhardt H, Sangle S, D'Cruz DP, Carr-White G, Marber M, Schnoes K, Arendt C, Klingel K, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. High-sensitive troponin is associated with subclinical imaging biosignature o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	number of deaths	1 year
Primary	Survival	number of deaths	5 year
Secondary	Rate of Heart Failure events	Number of participants with events including death and Hospitalisation due to Heart Failure	1 year
Secondary	Rate of Heart Failure events	Number of participants with events including death and Hospitalisation due to Heart Failure	5 year
Secondary	Rate of Arrhythmia	Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT	1 year
Secondary	Rate of Arrhythmia	Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT	5 year
Secondary	Rate of death due to to cardiovascular causes	Number of participants with death due to myocardial infarction, heart failure, arrhythmia	1 year
Secondary	Rate of death due to to cardiovascular causes	Number of participants with death due to myocardial infarction, heart failure, arrhythmia	5 year