Early Assessment of Anthracycline-induced Cardiotoxicity (CARDIOTOX)
NCT ID: NCT00195897
Last Updated: 2016-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
6 participants
OBSERVATIONAL
2006-01-31
2009-12-31
Brief Summary
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The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 y/o and \< 70 y/o
* WHO score \< or = 2
* Life expectancy \> 6 mo
* Left ventricular ejection fraction \> 50%
* Informed consent
Exclusion Criteria
* History of radiation therapy
* History of congestive heart failure
* History of chronic renal insufficiency
* Contra indication to MR examination
* Atrial fibrillation and significant arrhythmia
* Pregnancy
18 Years
70 Years
ALL
No
Sponsors
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Ligue contre le cancer, France
OTHER
Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Alain Manrique, MD
Role: STUDY_CHAIR
Centre Henri Becquerel
Fabrice Jardin, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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University Hospital of Rouen
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Countries
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References
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Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5. doi: 10.1093/annonc/mdf170.
Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. doi: 10.1056/NEJM199809243391307. No abstract available.
Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63. doi: 10.1159/000046508.
Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9. doi: 10.1067/mnc.2003.7.
Other Identifiers
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2005-001-CHB
Identifier Type: -
Identifier Source: org_study_id
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