International T1 Multicenter Outcome Study

NCT03749343 | Active Not Recruiting

• 1 other identifier: T1 Outcome 1/16gA
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

T1 mapping; native T1; native T2; accuracy; prognosis

Outcome Measures

Primary Outcomes (2)

• Survival

  number of deaths

  1 year

• Survival

  number of deaths

  5 year

Secondary Outcomes (6)

• Rate of Heart Failure events

  1 year

• Rate of Heart Failure events

  5 year

• Rate of Arrhythmia

  1 year

• Rate of Arrhythmia

  5 year

• Rate of death due to to cardiovascular causes

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults referred to clinical cardiac magnetic resonance imaging

You may qualify if:

• Adults (\>18 years of age)
• Able to provide informed consent
• Clinically indicated cardiac magnetic resonance imaging study

Sponsors & Collaborators

• Kerckhoff Klinik: collaborator
• Johann Wolfgang Goethe University Hospital: lead

Study Sites (2)

Kerckhoff Hospital

Bad Nauheim, Hesse, 61231, Germany

Location

Institute for experimental and translational cardiovascular imaging

Frankfurt am Main, Hesse, 60596, Germany

Location

Related Publications (4)

• 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.

  PMID: 29447739 RESULT

• 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.

  PMID: 30077990 RESULT

• 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.

  PMID: 30360992 RESULT

• 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.

  PMID: 33865770 DERIVED

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Coronary Artery Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Valentina Puentmann, MD, PhD

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 21, 2018
• Study Start: March 1, 2016
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

DE (2)