Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
International T1 Multicenter Outcome Study (the German Chapter)
Query!
Secondary ID [1]
0
0
T1 Outcome 1/16gA
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
T1Outcome-DE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Failure
0
0
Query!
Cardiomyopathies
0
0
Query!
Inflammatory Disease
0
0
Query!
Coronary Artery Disease
0
0
Query!
Chronic Kidney Diseases
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Survival
Query!
Assessment method [1]
0
0
number of deaths
Query!
Timepoint [1]
0
0
1 year
Query!
Primary outcome [2]
0
0
Survival
Query!
Assessment method [2]
0
0
number of deaths
Query!
Timepoint [2]
0
0
5 year
Query!
Secondary outcome [1]
0
0
Rate of Heart Failure events
Query!
Assessment method [1]
0
0
Number of participants with events including death and Hospitalisation due to Heart Failure
Query!
Timepoint [1]
0
0
1 year
Query!
Secondary outcome [2]
0
0
Rate of Heart Failure events
Query!
Assessment method [2]
0
0
Number of participants with events including death and Hospitalisation due to Heart Failure
Query!
Timepoint [2]
0
0
5 year
Query!
Secondary outcome [3]
0
0
Rate of Arrhythmia
Query!
Assessment method [3]
0
0
Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Query!
Timepoint [3]
0
0
1 year
Query!
Secondary outcome [4]
0
0
Rate of Arrhythmia
Query!
Assessment method [4]
0
0
Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Query!
Timepoint [4]
0
0
5 year
Query!
Secondary outcome [5]
0
0
Rate of death due to to cardiovascular causes
Query!
Assessment method [5]
0
0
Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Query!
Timepoint [5]
0
0
1 year
Query!
Secondary outcome [6]
0
0
Rate of death due to to cardiovascular causes
Query!
Assessment method [6]
0
0
Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Query!
Timepoint [6]
0
0
5 year
Query!
Eligibility
Key inclusion criteria
1. Adults (>18 years of age)
2. Able to provide informed consent
3. Clinically indicated cardiac magnetic resonance imaging study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Query!
Key exclusion criteria
contraindications for clinical cardiac magnetic resonance imaging due
to MR unsafe devices or objects
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/02/2030
Query!
Actual
Query!
Sample size
Target
8000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
Germany
Query!
State/province [1]
0
0
Hessen
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Johann Wolfgang Goethe University Hospital
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Kerckhoff Klinik
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Johannes Gutenberg University Mainz
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03749343
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
0
0
Valentina Puentmann, MD, PhD
Query!
Address
0
0
Goethe University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Valentina O Puentmann, MD, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03749343
Download to PDF