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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02407197




Registration number
NCT02407197
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
9/03/2023

Titles & IDs
Public title
International T1 Multicentre CMR Outcome Study
Scientific title
International T1 Multicentre CMR Study
Secondary ID [1] 0 0
2011-T1-MC
Universal Trial Number (UTN)
Trial acronym
T1-CMR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy 0 0
Heart Failure 0 0
Coronary Artery Disease 0 0
Chronic Kidney Diseases 0 0
Inflammation 0 0
Fibrosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Rate of Arrhythmia
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Rate of HF events
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Rate of deaths due to cardiovascular causes
Timepoint [3] 0 0
1 year

Eligibility
Key inclusion criteria
1. adults > 18 years of age
2. clinical indication for CMR
3. able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2022
Sample size
Target
Accrual to date
Final
1629
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Vincent's University - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
United Kingdom
State/province [2] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
King's College London
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02407197
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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. Erratum In: JACC Cardiovasc Imaging. 2017 Mar;10(3):384. doi: 10.1016/j.jcmg.2017.01.006.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Eike Nagel, MD, PhD
Address 0 0
King's College London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02407197