This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.
The primary purpose of the PROACT study is to test the accuracy of MyoStrain® to detect cardiotoxicity in patients on high risk cancer therapy. After undergoing baseline MRI and meeting eligibility criteria, patients will be further randomized to an unblinded arm (MyoStrain® measured and available to the treatment team) and a blinded arm (MyoStrain® measured but not available to the treatment team). This randomization will aid in an exploratory aim of testing the feasibility of MyoStrain® to guide cardioprotective therapy in the unblinded vs blinded arms. However, as all patients will have MyoStrain® measured, all patients (both treatment arms) will be combined for testing the primary outcome measure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
49
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
Washington University School of Medicine
St Louis, Missouri, United States
ROC AUC of MyoStrain® Compared to Standard CMR Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
The area under the curve refers to the area under the curve of Receiver operating characteristic curves (ROC AUC) to evaluate the accuracy of MyoStrain® to detect cardiotoxicity compared to Cardiovascular Magnetic Resonance (CMR) Imaging standard measurements. * Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity. * Clinical cardiotoxicity was defined as an absolute change in LVEF \> 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL. * In patients with LVEF \< 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \> 10% or a HF hospitalization. * Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP \>199 pg/mL.
Time frame: Through 36 months
Sensitivity of MyoStrain® Compared to CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Sensitivity is defined as the number of true positives divided by the number of true positives + number of false negatives. * Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity. * Clinical cardiotoxicity was defined as an absolute change in LVEF \> 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL. * In patients with LVEF \< 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \> 10% or a HF hospitalization. * Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP \>199 pg/mL
Time frame: Through 36 months
Specificity of MyoStrain® and CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specificity is defined as the number of true negatives divided by the number of true negatives + number of false positives. * Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity. * Clinical cardiotoxicity was defined as an absolute change in LVEF \> 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL. * In patients with LVEF \< 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \> 10% or a HF hospitalization. * Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP \> 199 pg/mL
Time frame: Through 36 months
Accuracy of MyoStrain® and CMR Standard Measurements (LV End Diastolic Volume Index, LV End Systolic Volume Index, LV Stroke Volume Index and Left Ventricular Ejection Fraction) to Detect Myocardial Dysfunction During Cancer Treatment
Accuracy is defined as (true positives + true negatives) divided by the total number of cases * Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity. * Clinical cardiotoxicity was defined as an absolute change in LVEF \> 10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL. * In patients with LVEF \< 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \> 10% or a HF hospitalization. * Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP \>199 pg/mL.
Time frame: Through 36 months
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
Myocardial dysfunction is the occurrence of either clinical or subclinical cardiotoxicity. * Clinical cardiotoxicity was defined as an absolute change in LVEF \>10% from baseline to below 53% combined with heart failure symptoms or elevation in NT pro BNP to above 199 pg/mL * In patients with LVEF \<53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \>10% or a HF hospitalization * Subclinical CTX was defined as an asymptomatic patient with a greater than 10% decrease in LVEF, worsening GLS more than 15% from baseline, or new elevation in NT pro BNP \>199 pg/mL
Time frame: Through 36 months