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International T1 Multicentre CMR Outcome Study (T1-CMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02407197
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Eike Nagel, King's College London

Study Description
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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.


Condition or disease
Cardiomyopathy Heart Failure Coronary Artery Disease Chronic Kidney Diseases Inflammation Fibrosis

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1629 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: International T1 Multicentre CMR Study
Actual Study Start Date : January 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 1 year ]
    number of deaths


Secondary Outcome Measures :
  1. Rate of Arrhythmia [ Time Frame: 1 year ]
    number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)

  2. Rate of HF events [ Time Frame: 1 year ]
    Number of HF death and unplanned HF hospitalization

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult population with clinically indicated CMR study
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407197


Locations
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Australia, New South Wales
Vincent's University
Sydney, New South Wales, Australia, NSW 2010
Germany
German Heart Institute Berlin
Berlin, Germany, 13353
United Kingdom
Guy's and St. Thomas' Hospital Trust
London, United Kingdom, SE1 7EH
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Eike Nagel, MD, PhD King's College London
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eike Nagel, Global Chief Investigator, King's College London
ClinicalTrials.gov Identifier: NCT02407197    
Other Study ID Numbers: 2011-T1-MC
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eike Nagel, King's College London:
T1 mapping
CMR
Outcome
multicenter
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Coronary Artery Disease
Cardiomyopathies
Inflammation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Urologic Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency