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Clinical Trials/NCT02407197
NCT02407197
Completed
Not Applicable

International T1 Multicentre CMR Study

King's College London4 sites in 3 countries1,629 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy
Sponsor
King's College London
Enrollment
1629
Locations
4
Primary Endpoint
Survival
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eike Nagel

Global Chief Investigator

King's College London

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Survival

Time Frame: 1 year

number of deaths

Secondary Outcomes

  • Rate of deaths due to cardiovascular causes(1 year)
  • Rate of HF events(1 year)
  • Rate of Arrhythmia(1 year)

Study Sites (4)

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