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International T1 Multicenter Outcome Study (T1Outcome-DE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749343
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Kerckhoff Klinik
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Valentina Puentmann, Johann Wolfgang Goethe University Hospital

Study Description
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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.

Condition or disease
Heart Failure Cardiomyopathies Inflammatory Disease Coronary Artery Disease Chronic Kidney Diseases

Study Design
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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International T1 Multicenter Outcome Study (the German Chapter)
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : February 28, 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    number of deaths

  2. Survival [ Time Frame: 5 year ]
    number of deaths


Secondary Outcome Measures :
  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


Biospecimen Retention:   None Retained
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults referred to clinical cardiac magnetic resonance imaging
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749343


Contacts
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Contact: Valentina O Puentmann, MD, PhD cvi-research@kgu.de
Contact: Franziska Weis cvi-research@kgu.de

Locations
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Germany
Kerckhoff Hospital Recruiting
Bad Nauheim, Hessen, Germany, 61231
Contact: Andreas Rolf         
Institute for experimental and translational cardiovascular imaging Recruiting
Frankfurt Am Main, Hessen, Germany, 60596
Contact: Valentina Puentmann, MD, PhD       cvi-research@kgu.de   
Contact: Franziska Weis       cvi-research@kgu.de   
Sub-Investigator: Eike Nagel, MD, PhD         
University Hospital Mainz Recruiting
Mainz, Hessen, Germany, 55131
Contact: Tilman Emrich, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Kerckhoff Klinik
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Valentina Puentmann, MD, PhD University Hospital, Frankfurt
More Information
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Publications of Results:

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Responsible Party: Valentina Puentmann, Principal Investigator, Clinical professor, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03749343    
Other Study ID Numbers: T1 Outcome 1/16gA
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valentina Puentmann, Johann Wolfgang Goethe University Hospital:
T1 mapping
native T1
native T2
accuracy
prognosis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Coronary Artery Disease
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
 Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency