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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03749343
Ethics application status
Date submitted
16/11/2018
Date registered
21/11/2018
Date last updated
3/04/2025

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
Assessment method [1] 0 0
number of deaths
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Survival
Assessment method [2] 0 0
number of deaths
Timepoint [2] 0 0
5 year
Secondary outcome [1] 0 0
Rate of Heart Failure events
Assessment method [1] 0 0
Number of participants with events including death and Hospitalisation due to Heart Failure
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Rate of Heart Failure events
Assessment method [2] 0 0
Number of participants with events including death and Hospitalisation due to Heart Failure
Timepoint [2] 0 0
5 year
Secondary outcome [3] 0 0
Rate of Arrhythmia
Assessment method [3] 0 0
Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Rate of Arrhythmia
Assessment method [4] 0 0
Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT
Timepoint [4] 0 0
5 year
Secondary outcome [5] 0 0
Rate of death due to to cardiovascular causes
Assessment method [5] 0 0
Number of participants with death due to myocardial infarction, heart failure, arrhythmia
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Rate of death due to to cardiovascular causes
Assessment method [6] 0 0
Number of participants with death due to myocardial infarction, heart failure, arrhythmia
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?
No
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
Active, not 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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Kerckhoff Klinik
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Johannes Gutenberg University Mainz
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT03749343