Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
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
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:
Condition category
Condition code

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

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
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)

Funding & Sponsors
Primary sponsor type
Other
Name
Johann Wolfgang Goethe University Hospital
Address
Country

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
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

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