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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02407197




Registration number
NCT02407197
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
26/02/2020

Titles & IDs
Public title
International T1 Multicentre CMR Outcome Study
Scientific title
International T1 Multicentre CMR Study
Secondary ID [1] 0 0
2011-T1-MC
Universal Trial Number (UTN)
Trial acronym
T1-CMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy 0 0
Heart Failure 0 0
Coronary Artery Disease 0 0
Chronic Kidney Diseases 0 0
Inflammation 0 0
Fibrosis 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]
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 - number of deaths
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Rate of Arrhythmia - number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Rate of HF events - Number of HF death and unplanned HF hospitalization
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Rate of deaths due to cardiovascular causes - Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
1. adults > 18 years of age

2. clinical indication for CMR

3. able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

contraindications for 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Vincent's University - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
King's College London
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Myocardial fibrosis is the fundamental substrate for the development of heart failure.

Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis
based on late gadolinium enhancement (LGE) and T1 mapping.

Patients: Prospective longitudinal observational multicenter study of consecutive patients
with suspected or known non-ischemic cardiomyopathy.

Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume
fraction (ECV) and LGE.

Primary endpoints: all cause and cardiovascular mortality.

Secondary endpoints: arrhythmic composite and HF composite endpoints.
Trial website
https://clinicaltrials.gov/show/NCT02407197
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eike Nagel, MD, PhD
Address 0 0
King's College London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications