Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
1629 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-01-31
Study Completion Date
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
International T1 Multicenter Outcome Study
NCT03749343
Heart Failure
Cardiomyopathies
Inflammatory Disease
+2 more
ACTIVE_NOT_RECRUITING
Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
NCT02352129
Cardiomyopathy, Dilated
COMPLETED
NA
T1 Mapping of Diffuse Myocardial Fibrosis in Congenital Heart Disease
NCT02350829
Cardiomyopathy
COMPLETED
NA
Improved Detection of Myocardial Fibrosis: a Cardiovascular Magnetic Resonance Imaging Study
NCT06697509
Myocardial Diseases
ENROLLING_BY_INVITATION
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
NCT04063579
Heart Failure With Preserved Ejection Fraction
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cardiomyopathy
Heart Failure
Coronary Artery Disease
Chronic Kidney Diseases
Inflammation
Fibrosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. adults \> 18 years of age
2. clinical indication for CMR
3. able to provide informed consent
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College London
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eike Nagel
Global Chief Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eike Nagel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vincent's University
Sydney, New South Wales, Australia
Site Status
German Heart Institute Berlin
Berlin, , Germany
Site Status
Guy's and St. Thomas' Hospital Trust
London, , United Kingdom
Site Status
King's College Hospital
London, , United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Australia
Germany
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Dabir D, Child N, Kalra A, Rogers T, Gebker R, Jabbour A, Plein S, Yu CY, Otton J, Kidambi A, McDiarmid A, Broadbent D, Higgins DM, Schnackenburg B, Foote L, Cummins C, Nagel E, Puntmann VO. Reference values for healthy human myocardium using a T1 mapping methodology: results from the International T1 Multicenter cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2014 Oct 21;16(1):69. doi: 10.1186/s12968-014-0069-x.
Reference Type
RESULT
Hinojar R, Foote L, Arroyo Ucar E, Jackson T, Jabbour A, Yu CY, McCrohon J, Higgins DM, Carr-White G, Mayr M, Nagel E, Puntmann VO. Native T1 in discrimination of acute and convalescent stages in patients with clinical diagnosis of myocarditis: a proposed diagnostic algorithm using CMR. JACC Cardiovasc Imaging. 2015 Jan;8(1):37-46. doi: 10.1016/j.jcmg.2014.07.016. Epub 2014 Dec 10.
Reference Type
RESULT
Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.
Reference Type
RESULT
Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Rolf A, Zitzmann S, Peker E, D'Angelo T, Pathan F, Elen, Valbuena S, Hinojar R, Arendt C, Narula J, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. Native T1 and ECV of Noninfarcted Myocardium and Outcome in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 20;71(7):766-778. doi: 10.1016/j.jacc.2017.12.020.
Reference Type
RESULT
Child N, Suna G, Dabir D, Yap ML, Rogers T, Kathirgamanathan M, Arroyo-Ucar E, Hinojar R, Mahmoud I, Young C, Wendler O, Mayr M, Sandhu B, Morton G, Muhly-Reinholz M, Dimmeler S, Nagel E, Puntmann VO. Comparison of MOLLI, shMOLLLI, and SASHA in discrimination between health and disease and relationship with histologically derived collagen volume fraction. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):768-776. doi: 10.1093/ehjci/jex309.
Reference Type
RESULT
Puntmann VO, Isted A, Hinojar R, Foote L, Carr-White G, Nagel E. T1 and T2 Mapping in Recognition of Early Cardiac Involvement in Systemic Sarcoidosis. Radiology. 2017 Oct;285(1):63-72. doi: 10.1148/radiol.2017162732. Epub 2017 Apr 27.
Reference Type
RESULT
Hinojar R, Foote L, Sangle S, Marber M, Mayr M, Carr-White G, D'Cruz D, Nagel E, Puntmann VO. Native T1 and T2 mapping by CMR in lupus myocarditis: Disease recognition and response to treatment. Int J Cardiol. 2016 Nov 1;222:717-726. doi: 10.1016/j.ijcard.2016.07.182. Epub 2016 Aug 3.
Reference Type
RESULT
Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Hinojar R, Doltra A, Varma N, Child N, Rogers T, Suna G, Arroyo Ucar E, Goodman B, Khan S, Dabir D, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. T1-Mapping and Outcome in Nonischemic Cardiomyopathy: All-Cause Mortality and Heart Failure. JACC Cardiovasc Imaging. 2016 Jan;9(1):40-50. doi: 10.1016/j.jcmg.2015.12.001.
Reference Type
RESULT
Hinojar R, Varma N, Child N, Goodman B, Jabbour A, Yu CY, Gebker R, Doltra A, Kelle S, Khan S, Rogers T, Arroyo Ucar E, Cummins C, Carr-White G, Nagel E, Puntmann VO. T1 Mapping in Discrimination of Hypertrophic Phenotypes: Hypertensive Heart Disease and Hypertrophic Cardiomyopathy: Findings From the International T1 Multicenter Cardiovascular Magnetic Resonance Study. Circ Cardiovasc Imaging. 2015 Dec;8(12):e003285. doi: 10.1161/CIRCIMAGING.115.003285.
Reference Type
RESULT
Isted A, Grigoratos C, Bratis K, Carr-White G, Nagel E, Puntmann VO. Native T1 in deciphering the reversible myocardial inflammation in cardiac sarcoidosis with anti-inflammatory treatment. Int J Cardiol. 2016 Jan 15;203:459-62. doi: 10.1016/j.ijcard.2015.10.199. Epub 2015 Oct 29. No abstract available.
Reference Type
RESULT
Varma N, Hinojar R, D'Cruz D, Arroyo Ucar E, Indermuehle A, Peel S, Greil G, Gaddum N, Chowienczyk P, Nagel E, Botnar RM, Puntmann VO. Coronary vessel wall contrast enhancement imaging as a potential direct marker of coronary involvement: integration of findings from CAD and SLE patients. JACC Cardiovasc Imaging. 2014 Aug;7(8):762-70. doi: 10.1016/j.jcmg.2014.03.012. Epub 2014 Jul 16.
Reference Type
RESULT
Puntmann VO, Arroyo Ucar E, Hinojar Baydes R, Ngah NB, Kuo YS, Dabir D, Macmillan A, Cummins C, Higgins DM, Gaddum N, Chowienczyk P, Plein S, Carr-White G, Nagel E. Aortic stiffness and interstitial myocardial fibrosis by native T1 are independently associated with left ventricular remodeling in patients with dilated cardiomyopathy. Hypertension. 2014 Oct;64(4):762-8. doi: 10.1161/HYPERTENSIONAHA.114.03928. Epub 2014 Jul 14.
Reference Type
RESULT
Rogers T, Dabir D, Mahmoud I, Voigt T, Schaeffter T, Nagel E, Puntmann VO. Standardization of T1 measurements with MOLLI in differentiation between health and disease--the ConSept study. J Cardiovasc Magn Reson. 2013 Sep 11;15(1):78. doi: 10.1186/1532-429X-15-78.
Reference Type
RESULT
Puntmann VO, Voigt T, Chen Z, Mayr M, Karim R, Rhode K, Pastor A, Carr-White G, Razavi R, Schaeffter T, Nagel E. Native T1 mapping in differentiation of normal myocardium from diffuse disease in hypertrophic and dilated cardiomyopathy. JACC Cardiovasc Imaging. 2013 Apr;6(4):475-84. doi: 10.1016/j.jcmg.2012.08.019. Epub 2013 Mar 14.
Reference Type
RESULT
Puntmann VO, D'Cruz D, Smith Z, Pastor A, Choong P, Voigt T, Carr-White G, Sangle S, Schaeffter T, Nagel E. Native myocardial T1 mapping by cardiovascular magnetic resonance imaging in subclinical cardiomyopathy in patients with systemic lupus erythematosus. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):295-301. doi: 10.1161/CIRCIMAGING.112.000151. Epub 2013 Feb 12.
Reference Type
RESULT
Hoffmann J, Puntmann VO, Fiser K, Rasper T, Berkowitsch A, Carerj ML, Nagel E, Dimmeler S, Zeiher AM. Circulating Th17 and Th22 Cells Are Associated With CMR Imaging Biosignatures of Diffuse Myocardial Interstitial Remodeling in Chronic Coronary Artery Disease. Circ Res. 2020 Aug 14;127(5):699-701. doi: 10.1161/CIRCRESAHA.120.316619. Epub 2020 Jun 24. No abstract available.
Reference Type
DERIVED
Winau L, Hinojar Baydes R, Braner A, Drott U, Burkhardt H, Sangle S, D'Cruz DP, Carr-White G, Marber M, Schnoes K, Arendt C, Klingel K, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. High-sensitive troponin is associated with subclinical imaging biosignature of inflammatory cardiovascular involvement in systemic lupus erythematosus. Ann Rheum Dis. 2018 Nov;77(11):1590-1598. doi: 10.1136/annrheumdis-2018-213661. Epub 2018 Aug 4.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-T1-MC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)
NCT07335770
ENROLLING_BY_INVITATION
Evaluation of Myocardial Iron Deposition in Patients of Heart Failure Using T2* MR Imaging
NCT02527330
COMPLETED
French National Observatory Tracking Viral Myocarditis: Mortality, Cardiovascular Events, Sequels on (Magnetic Resonance Imaging) MRI
NCT02717143
COMPLETED
Characterization of Myocardial Interstitial Fibrosis and Cardiomyocyte Hypertrophy by Cardiac MRI in Heart Failure
NCT03084679
UNKNOWN
NA
Multimodal Imaging Assessment of Chronic Kidney Disease Patients at Different Stages From a Cardio-Renal Interaction Perspective
NCT07107919
RECRUITING
IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
NCT04444128
RECRUITING
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
NCT06316661
RECRUITING
Molecular MRI of the Fibrotic Heart
NCT02012725
TERMINATED
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
NCT06409585
RECRUITING
Association of T1-mapping and LV Strain Analysis by CMR
NCT03405987
UNKNOWN
Cardiac Magnetic Resonance Tomography for Heart Failure With Preserved Ejection Fraction
NCT05322109
COMPLETED
Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis
NCT04862273
ACTIVE_NOT_RECRUITING
Myocardial Fibrosis, Function and Aging
NCT03064503
UNKNOWN
NA
Magnetic Resonance Imaging Development for High Resolution Atrial Structural and Functional Characterization
NCT06617624
NOT_YET_RECRUITING
CT-based Myocardial Characterization (CTMyoC)
NCT06029400
RECRUITING
Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR
NCT00549861
COMPLETED
NA
Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area
NCT06552845
RECRUITING
Multimodality Imaging in the Screening, Diagnosis and Risk StratifictiON of HFpEF
NCT04603404
RECRUITING
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
NCT04464655
RECRUITING
Multimodal Cardiovascular Magnetic Resonance Imaging for Cardiometabolic Pre-HF and HFpEF
NCT07336316
ENROLLING_BY_INVITATION
Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
NCT04990297
RECRUITING
Magnetic Resonance Imaging (MRI) Viability: Comparison of Myocardial Viability by Positron Emission Tomography and MRI
NCT00166179
COMPLETED
CMR for Prognosis Assessment in NSTEMI
NCT03516578
COMPLETED