International T1 Multicenter Outcome Study (T1Outcome-DE)

International T1 Multicenter Outcome Study (the German Chapter)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Franziska Weis; Email: cvi-research@kgu.de
• Study Contact Backup: Name: Valentina O Puentmann, MD, PhD; Email: cvi-research@kgu.de

Study Locations

• Germany
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Recruiting
      • Kerckhoff Hospital
      • Contact: Andreas Rolf
    • Frankfurt Am Main, Hessen, Germany, 60596
      • Recruiting
      • Institute for experimental and translational cardiovascular imaging
      • Contact: Valentina Puentmann, MD, PhD; Email: cvi-research@kgu.de
      • Contact: Franziska Weis; Email: cvi-research@kgu.de
      • Sub-Investigator: Eike Nagel, MD, PhD
    • Mainz, Hessen, Germany, 55131
      • Recruiting
      • University Hospital Mainz
      • Contact: Tilman Emrich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults referred to clinical cardiac magnetic resonance imaging

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	number of deaths	5 year
Survival	number of deaths	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Heart Failure events	Number of participants with events including death and Hospitalisation due to Heart Failure	1 year
Rate of Heart Failure events	Number of participants with events including death and Hospitalisation due to Heart Failure	5 year
Rate of Arrhythmia	Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT	1 year
Rate of Arrhythmia	Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT	5 year
Rate of death due to to cardiovascular causes	Number of participants with death due to myocardial infarction, heart failure, arrhythmia	1 year
Rate of death due to to cardiovascular causes	Number of participants with death due to myocardial infarction, heart failure, arrhythmia	5 year

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: Johannes Gutenberg University Mainz; Kerckhoff Klinik
• Investigators: Principal Investigator: Valentina Puentmann, MD, PhD, Goethe University

Publications and helpful links

General Publications

• 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 T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.
• 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 and ECV of Noninfarcted Myocardium and Outcome in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 20;71(7):766-778. doi: 10.1016/j.jacc.2017.12.020.
• 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 of inflammatory cardiovascular involvement in systemic lupus erythematosus. Ann Rheum Dis. 2018 Nov;77(11):1590-1598. doi: 10.1136/annrheumdis-2018-213661. Epub 2018 Aug 4.
• de Leuw P, Arendt CT, Haberl AE, Froadinadl D, Kann G, Wolf T, Stephan C, Schuettfort G, Vasquez M, Arcari L, Zhou H, Zainal H, Gawor M, Vidalakis E, Kolentinis M, Albrecht MH, Escher F, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. Myocardial Fibrosis and Inflammation by CMR Predict Cardiovascular Outcome in People Living With HIV. JACC Cardiovasc Imaging. 2021 Aug;14(8):1548-1557. doi: 10.1016/j.jcmg.2021.01.042. Epub 2021 Apr 14.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: prognosis; accuracy; T1 mapping; native T1; native T2
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Coronary Disease; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Kidney Diseases; Renal Insufficiency, Chronic; Cardiomyopathies
• Other Study ID Numbers: T1 Outcome 1/16gA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No