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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

Tracking Information
First Submitted Date November 16, 2018
First Posted Date November 21, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date March 1, 2016
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2018)
  • Survival [ Time Frame: 1 year ]
    number of deaths
  • Survival [ Time Frame: 5 year ]
    number of deaths
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 19, 2018)
  • Rate of Heart Failure events [ Time Frame: 1 year ]
    Number of participants with events including death and Hospitalisation due to Heart Failure
  • Rate of Heart Failure events [ Time Frame: 5 year ]
    Number of participants with events including death and Hospitalisation due to Heart Failure
  • Rate of Arrhythmia [ Time Frame: 1 year ]
    Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
  • Rate of Arrhythmia [ Time Frame: 5 year ]
    Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
  • Rate of death due to to cardiovascular causes [ Time Frame: 1 year ]
    Number of participants with death due to myocardial infarction, heart failure, arrhythmia
  • Rate of death due to to cardiovascular causes [ Time Frame: 5 year ]
    Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International T1 Multicenter Outcome Study
Official Title International T1 Multicenter Outcome Study (the German Chapter)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Adults referred to clinical cardiac magnetic resonance imaging
Condition
  • Heart Failure
  • Cardiomyopathies
  • Inflammatory Disease
  • Coronary Artery Disease
  • Chronic Kidney Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2018)
8000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2024
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Valentina O Puentmann, MD, PhD cvi-research@kgu.de
Contact: Franziska Weis cvi-research@kgu.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03749343
Other Study ID Numbers T1 Outcome 1/16gA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Valentina Puentmann, Johann Wolfgang Goethe University Hospital
Study Sponsor Johann Wolfgang Goethe University Hospital
Collaborators
  • Kerckhoff Klinik
  • Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Valentina Puentmann, MD, PhD University Hospital, Frankfurt
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date November 2018