International T1 Multicentre CMR Outcome Study

Completed

• Conditions: Heart Failure; Coronary Artery Disease; Fibrosis; Cardiomyopathy; Chronic Kidney Diseases; Inflammation

• Registration Number: NCT02407197
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-02
• Primary Completion: 2017-12
• Study Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1629

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	1 year	number of deaths

Secondary Outcome Measures

Name	Time	Method
Rate of deaths due to cardiovascular causes	1 year	Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event
Rate of HF events	1 year	Number of HF death and unplanned HF hospitalization
Rate of Arrhythmia	1 year	number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)

Trial Locations

Locations (4)

Guy's and St. Thomas' Hospital Trust; 🇬🇧 London, United Kingdom

Vincent's University; 🇦🇺 Sydney, New South Wales, Australia

German Heart Institute Berlin; 🇩🇪 Berlin, Germany

King's College Hospital; 🇬🇧 London, United Kingdom