Cancer Survivor Cardiomyopathy Detection

Study Overview
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Brief Summary
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The purpose of this study is to improve the cardiovascular care of adult cancer survivors. The goal is to obtain the data necessary to plan and develop a nation-wide network of a screening program that can help provide cost-effective and long-term monitoring.

Detailed Description
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The primary objective of this study is to define the diagnostic performance and optimal cutoffs of AI-ECG and NT-pro-BNP for the detection of left ventricular dysfunction (LVD, defined as a left ventricular ejection fraction (LVEF) <50%) in cancer patients at 1 year after completion of anthracycline-based chemotherapy.

Official Title
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Cancer Survivor Cardiomyopathy Detection

Conditions
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Cardiovascular Diseases, Cancer

Intervention / Treatment
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* Diagnostic Test: NT-pro-BNP
* Diagnostic Test: Electrocardiogram
* Diagnostic Test: Echocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age at the time of enrollment diagnosis of breast cancer, lymphoma, or sarcoma with either planned or at 1 year after completion of anthracycline therapy, including patients from 6-12 months and greater than 1 year post-anthracycline exposure. Exclusion Criteria: LVEF <50% or prior confirmed history of cardiomyopathy, heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm Individuals with pacemakers, defibrillators, or other implanted electronic devices Diagnosed with stage 4 Diagnosed with metastatic disease not being treated with curative intent Prior or planned HER2-directed chemotherapy Inability/unwillingness of individual to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 year follow-up<br>patients who were treated in the year before and are now returning for their 1-year follow-up. | Diagnostic Test: NT-pro-BNP<br>* Blood draw<br>* Other names: Blood Biomarker;Diagnostic Test: Electrocardiogram<br>* electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart<br>Diagnostic Test: Echocardiogram<br>* medical imaging of the heart<br>|
| Prior to anthracycline-based therapy<br>patients presenting before the start of anthracycline-based therapy, then to be followed thereafter for 1 year and thereby contributing to the pool of patients with 1-year post-anthracycline assessment. | Diagnostic Test: NT-pro-BNP<br>* Blood draw<br>* Other names: Blood Biomarker;Diagnostic Test: Electrocardiogram<br>* electrodes are placed on certain spots and a reading obtained to measure the voltage of the heart<br>Diagnostic Test: Echocardiogram<br>* medical imaging of the heart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of AI-ECG for left ventricular ejection fraction (LVEF) < 50% | Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm for an LVEF <50% | 1 year post anthracycline therapy | 
| Diagnostic performance of NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50% | Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for NT-pro-BNP >125 for an LVEF <50% | 1 year post anthracycline therapy | 
| Diagnostic performance of AI-ECG and NT-pro-BNP for left ventricular ejection fraction (LVEF) < 50% | Determination of the sensitivity, specificity, positive and negative prediction value as well as area under the curve for receiver operating characteristics for the 12-lead AI ECG algorithm and NT-pro-BNP >125 combined for an LVEF <50% | 1 year post anthracycline therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in LVEF from baseline to 1 year from anthracycline-based therapy | Calculation of the the change in LVEF from baseline to 1 year from anthracycline-based therapy | 1 year | 
| Absolute change in AI-ECG probability for LVEF <50% from baseline to 1 year from anthracycline-based therapy | Calculation of the change in AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy | 1 year | 
| Correlation of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy | Calculation of the correlation coefficient of change in LVEF and AI-ECG probability of LVEF <50% from baseline to 1 year from anthracycline-based therapy | 1 year | 
| Absolute change in NT-pro-BNP from baseline to 1 year from anthracycline-based therapy | Calculation of the change NT-pro-BNP from baseline to 1 year from anthracycline-based therapy | 1 year | 
| Correlation of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy | Calculation of the correlation coefficient of change in LVEF and NT-pro-BNP from baseline to 1 year from anthracycline-based therapy | 1 year |