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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/NCT02407197
Registration number
NCT02407197
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
9/03/2023
Titles & IDs
Public title
International T1 Multicentre CMR Outcome Study
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Scientific title
International T1 Multicentre CMR Study
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Secondary ID [1]
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2011-T1-MC
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Universal Trial Number (UTN)
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Trial acronym
T1-CMR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy
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Heart Failure
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Coronary Artery Disease
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Chronic Kidney Diseases
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Inflammation
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Fibrosis
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Cardiovascular
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0
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Coronary heart disease
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survival
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Assessment method [1]
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number of deaths
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Rate of Arrhythmia
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Assessment method [1]
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number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Rate of HF events
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Assessment method [2]
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Number of HF death and unplanned HF hospitalization
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Rate of deaths due to cardiovascular causes
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Assessment method [3]
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Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event
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Timepoint [3]
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1 year
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Eligibility
Key inclusion criteria
1. adults > 18 years of age
2. clinical indication for CMR
3. able to provide informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or
objects
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2022
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Sample size
Target
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Accrual to date
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Final
1629
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Vincent's University - Sydney
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Recruitment postcode(s) [1]
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NSW 2010 - Sydney
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Country [2]
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United Kingdom
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State/province [2]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
King's College London
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02407197
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eike Nagel, MD, PhD
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Address
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King's College London
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02407197
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