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          Imaging in Cardio-Oncology Study (iCOS)

          Closed for proposals

          Project Type

          Coordinated Research Project

          Project Code

          E13047

          CRP

          2158

          Approved Date

          4 December 2018

          Status

          Active - Ongoing

          Start Date

          27 March 2019

          Expected End Date

          28 September 2025

          Participating Countries

          Brazil
          Croatia
          Cuba
          Czech Republic
          Greece
          Hungary
          India
          Mexico
          Serbia
          Thailand
          Türkiye
          United States of America

          Description

          Anthracyclines remain an important drug for the treatment of many solid tumors, including breast cancer. However, its use is primarily limited by the development of irreversible left ventricular dysfunction (chemotherapy related cardiac dysfunction, CTRD). Current monitoring for CTRD relies on the quantitative and reproducible assessment of left ventricular ejection fraction (LVEF) either by equilibrium radionuclide angiocardiography (ERNA) or echocardiography. This method of monitoring does not allow for the detection of CTRD until left ventricular dysfunction actually occurs. Therefore, novel methods of detecting cardiotoxicity before the onset of CTRD would allow treatment with cardioprotective drugs to prevent CTRD. Several potential ERNA and echocardiographic parameters may provide important predictive information identifying individuals who might benefit from cardioprotective therapy.?Based on this background, the current study proposes to evaluate several ERNA and echocardiographic parameters at baseline (pre-chemotherapy) and early in breast cancer treatment with anthracycline based therapy (between the first and second chemotherapy cycles). The study will determine if (1) baseline imaging parameters and/or (2) imaging parameters acquired early in chemotherapy can identify those individuals who ultimately develop CTRCD.?Ultimately, this study will identify important noninvasive imaging parameters that can reduce the risk of developing CTRCD in women receiving anthracycline-based chemotherapy for breast cancer.?LIST OF ABBREVIATIONS?CAD: coronary artery diseaseCVD: cardiovascular diseasesCTRCD: chemotherapy related cardiac dysfunctionCR: complete revascularizationCABG: coronary artery bypass graftEGFR: estimated glomerular filtration rateECG: electrocardiogramERNA: equilibrium radionuclide angiocardiographyEDV: end-diastolic volumeESV: end-systolic volumeFFR: fractional flow reserveGLS: global longitudinal strainLV: left ventricularLVEF: left ventricular ejection fractionLMICs: low- and middle-income countriesMACE: major adverse cardiac events MI: myocardial infarctionMPI: myocardial perfusion imagingPCI: percutaneous coronary interventionRCT: randomized controlled trial

          Objectives

          The overall objective of the CRP is to determine the early predictors of CTRCD from anthracycline-based chemotherapy at 1 year after completion of anthracycline therapy in women with breast cancer.

          Specific objectives

          The primary research aim of our study is: To determine early (within 6 weeks of chemotherapy initiation) imaging based (echocardiographic and equilibrium radionuclide angiocardiography) predictors of left ventricular systolic dysfunction or heart failure at one year, in women with breast cancer receiving anthracycline-based chemotherapy.

          The secondary research aim of our study is: To determine racial, ethnic, regional, and clinical differences in the development of left ventricular systolic dysfunction or heart failure at one year, in women with breast cancer receiving anthracycline-based chemotherapy globally.

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