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
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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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||1629 participants|
|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|
- Survival [ Time Frame: 1 year ]number of deaths
- 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
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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|
- adults > 18 years of age
- clinical indication for CMR
- able to provide informed consent
contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects
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
|Australia, New South Wales|
|Sydney, New South Wales, Australia, NSW 2010|
|German Heart Institute Berlin|
|Berlin, Germany, 13353|
|Guy's and St. Thomas' Hospital Trust|
|London, United Kingdom, SE1 7EH|
|King's College Hospital|
|London, United Kingdom, SE5 9RS|
|Principal Investigator:||Eike Nagel, MD, PhD||King's College London|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eike Nagel, Global Chief Investigator, King's College London|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Renal Insufficiency, Chronic
Coronary Artery Disease
Arterial Occlusive Diseases