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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

Titles & IDs

Public title

International T1 Multicentre CMR Outcome Study

Scientific title

International T1 Multicentre CMR Study

Secondary ID [1]

2011-T1-MC

Universal Trial Number (UTN)

Trial acronym

T1-CMR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiomyopathy

Heart Failure

Coronary Artery Disease

Chronic Kidney Diseases

Inflammation

Fibrosis

Condition category

Condition code

Renal and Urogenital

Kidney disease

Renal and Urogenital

Other renal and urogenital disorders

Cardiovascular

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]

Survival

Assessment method [1]

number of deaths

Timepoint [1]

1 year

Secondary outcome [1]

Rate of Arrhythmia

Assessment method [1]

number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD)

Timepoint [1]

1 year

Secondary outcome [2]

Rate of HF events

Assessment method [2]

Number of HF death and unplanned HF hospitalization

Timepoint [2]

1 year

Secondary outcome [3]

Rate of deaths due to cardiovascular causes

Assessment method [3]

Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event

Timepoint [3]

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?

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]

Vincent's University - Sydney

Recruitment postcode(s) [1]

NSW 2010 - Sydney

Recruitment outside Australia

Country [1]

Germany

State/province [1]

Berlin

Country [2]

United Kingdom

State/province [2]

London

Funding & Sponsors

Primary sponsor type

Other

Name

King's College London

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

Eike Nagel, MD, PhD

Address

King's College London

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Type	Citations or Other Details
Journal	Dabir D, Child N, Kalra A, Rogers T, Gebker R, Jab... [More Details]
Journal	Hinojar R, Foote L, Arroyo Ucar E, Jackson T, Jabb... [More Details]
Journal	Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal ... [More Details]
Journal	Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebke... [More Details]
Journal	Child N, Suna G, Dabir D, Yap ML, Rogers T, Kathir... [More Details]
Journal	Puntmann VO, Isted A, Hinojar R, Foote L, Carr-Whi... [More Details]
Journal	Hinojar R, Foote L, Sangle S, Marber M, Mayr M, Ca... [More Details]
Journal	Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebke... [More Details]
Journal	Hinojar R, Varma N, Child N, Goodman B, Jabbour A,... [More Details]
Journal	Isted A, Grigoratos C, Bratis K, Carr-White G, Nag... [More Details]
Journal	Varma N, Hinojar R, D'Cruz D, Arroyo Ucar E, Inder... [More Details]
Journal	Puntmann VO, Arroyo Ucar E, Hinojar Baydes R, Ngah... [More Details]
Journal	Rogers T, Dabir D, Mahmoud I, Voigt T, Schaeffter ... [More Details]
Journal	Puntmann VO, Voigt T, Chen Z, Mayr M, Karim R, Rho... [More Details]
Journal	Puntmann VO, D'Cruz D, Smith Z, Pastor A, Choong P... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT02407197

Register a trial

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