Imaging in Cardio-Oncology Study (iCOS)

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E13047

CRP

2158

Approved Date

4 December 2018

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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