Clinical Trial: Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Doxorubicin-associated Cardiac Tissue Remodeling Followed by CMR of Myocardial Extracellular Volume and Myocyte Size in Breast Cancer Patients
Brief Summary: Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva, Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each DOX-cycle.
Detailed Summary:
This prospective cohort study was performed at the State University of Campinas, Brazil. The Institutional Review Board of the State University of Campinas approved the study and all participants provided informed consent. Female patients with breast cancer who received anthracycline (doxorubicin or daunorubicin or epirubicin) as part of their chemotherapy protocol were enrolled in the study.
Detailed medical history, standard anthropometric data, and measurement hemogram, troponin, CKMB, cholesterol, serum glucose, CRP and biomarkers were obtained.
As in adults, chronic anthracycline-related cardiotoxicity typically presents early, within one year after termination of chemotherapy and the peak time for the appearance of symptoms of heart failure is about three months after the last anthracycline dose, patients underwent CMR before and three times serially after DOX (two, five and twelve months).
Patients were imaged in supine position in a 3T magnet (Achieva, Philips Medical Systems, Best, The Netherlands). The CMR protocol consisted of electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular (LV) function and LV mass. For imaging of late gadolinium enhancement (LGE) we used an inversion-recovery-prepared, gradient-echo sequence with segmented acquisition, which was triggered every other heartbeat. LGE images were acquired during end-expiratory breath-holding for slices matching the slice locations for cine imaging, starting within 10 min after bolus administration of a cumulative dose of 0.2 mmol/Kg of gadoterate meglumine (Dotarem, Guerbet, Aulnay-sous-Bois, France). T1 was performed with a Look-Locker sequence with a non-slice-selective adiabatic inversion pulse, followed by segmented gradient-echo acquisition for 17 times
Sponsor: University of Campinas, Brazil
Current Primary Outcome:
- Quantification of fibrosis index by Cardiac Magnetic Resonance [ Time Frame: two years ]Estimate the extracellular volume fraction derived from gadolinium-DTPA partition Coefficient of the myocardium
- Intracellular lifetime of water (τic) by Cardiac Magnetic Resonance [ Time Frame: two years ]This metric estimates the myocyte size using Cardiac Magnetic Resonance T1 mapping data
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Left ventricular mass by Cardiac Magnetic Resonance [ Time Frame: two years ]Electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular mass.
- Left ventricular volumes by Cardiac Magnetic Resonance [ Time Frame: two years ]Electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular volume.
- Left ventricular ejection fraction by Cardiac Magnetic Resonance [ Time Frame: two years ]Electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular ejection fraction.
- Left ventricular myocardial edema fraction by Cardiac Magnetic Resonance [ Time Frame: two years ]Using T2-weighted sequences to visualize myocardial edema
Original Secondary Outcome: Same as current
Information By: University of Campinas, Brazil
Dates:
Date Received: November 28, 2016
Date Started: July 2012
Date Completion:
Last Updated: December 18, 2016
Last Verified: December 2016
