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International T1 Multicentre CMR Outcome Study

International T1 Multicentre CMR Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02407197
Acronym
T1-CMR
Enrollment
1629
Registered
2015-04-02
Start date
2011-01-31
Completion date
2022-12-01
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Chronic Kidney Diseases, Coronary Artery Disease, Fibrosis, Heart Failure, Inflammation

Keywords

T1 mapping, CMR, Outcome, multicenter

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.

Interventions

None listed

Sponsors

King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. adults \> 18 years of age 2. clinical indication for CMR 3. able to provide informed consent

Exclusion criteria

contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects

Design outcomes

Primary

MeasureTime frameDescription
Survival1 yearnumber of deaths

Secondary

MeasureTime frameDescription
Rate of Arrhythmia1 yearnumber of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)
Rate of HF events1 yearNumber of HF death and unplanned HF hospitalization
Rate of deaths due to cardiovascular causes1 yearNumber of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event

Countries

Australia, Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026