International T1 Multicentre CMR Outcome Study

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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Key information

Conditions

Cardiomyopathy Arterial Occlusive Diseases Arteriosclerosis Cardiomyopathies Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Coronary Artery Disease Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Heart Diseases Heart Failure Inflammation Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vincent's University, Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adults > 18 years of age
clinical indication for CMR
able to provide informed consent

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Survival

Time frame: 1 year

number of deaths

Secondary outcomes

Rate of Arrhythmia

Time frame: 1 year

number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)
Rate of HF events

Time frame: 1 year

Number of HF death and unplanned HF hospitalization
Rate of deaths due to cardiovascular causes

Time frame: 1 year

Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

International T1 Multicentre CMR Study

Acronym: T1-CMR

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2022
First posted: Apr 2, 2015
Registry last updated: Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed