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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03749343




Registration number
NCT03749343
Ethics application status
Date submitted
16/11/2018
Date registered
21/11/2018
Date last updated
13/07/2023

Titles & IDs
Public title
International T1 Multicenter Outcome Study
Scientific title
International T1 Multicenter Outcome Study (the German Chapter)
Secondary ID [1] 0 0
T1 Outcome 1/16gA
Universal Trial Number (UTN)
Trial acronym
T1Outcome-DE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Cardiomyopathies 0 0
Inflammatory Disease 0 0
Coronary Artery Disease 0 0
Chronic Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Survival
Timepoint [2] 0 0
5 year
Secondary outcome [1] 0 0
Rate of Heart Failure events
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Rate of Heart Failure events
Timepoint [2] 0 0
5 year
Secondary outcome [3] 0 0
Rate of Arrhythmia
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Rate of Arrhythmia
Timepoint [4] 0 0
5 year
Secondary outcome [5] 0 0
Rate of death due to to cardiovascular causes
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Rate of death due to to cardiovascular causes
Timepoint [6] 0 0
5 year

Eligibility
Key inclusion criteria
1. Adults (>18 years of age)

2. Able to provide informed consent

3. Clinically indicated cardiac magnetic resonance imaging study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
contraindications for clinical cardiac magnetic resonance imaging due
to MR unsafe devices or objects

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2030
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hessen

Funding & Sponsors
Primary sponsor type
Other
Name
Johann Wolfgang Goethe University Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Kerckhoff Klinik
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Johannes Gutenberg University Mainz
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03749343
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Valentina Puentmann, MD, PhD
Address 0 0
Goethe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Valentina O Puentmann, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
cvi-research@kgu.de
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03749343