{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.5","upperLimit":"85.2","value":"77.9"},{"groupId":"OG001","lowerLimit":"81.6","upperLimit":"95.1","value":"88.4"},{"groupId":"OG002","lowerLimit":"67.6","upperLimit":"79.6","value":"73.6"}]}],"title":"MyoStrain®"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"91.2","upperLimit":"98.9","value":"95.0"},{"groupId":"OG001","lowerLimit":"84.2","upperLimit":"96.8","value":"90.5"},{"groupId":"OG002","lowerLimit":"81.6","upperLimit":"91.0","value":"86.3"}]}],"title":"CMR LVEF"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"67.5","upperLimit":"82.9","value":"75.2"},{"groupId":"OG001","lowerLimit":"41.7","upperLimit":"63.1","value":"52.4"},{"groupId":"OG002","lowerLimit":"54.8","upperLimit":"68.1","value":"61.5"}]}],"title":"CMR left ventricular end-diastolic indexed (LVEDVI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"97.6","upperLimit":"100.0","value":"99.2"},{"groupId":"OG001","lowerLimit":"59.2","upperLimit":"78.9","value":"69.0"},{"groupId":"OG002","lowerLimit":"70.8","upperLimit":"82.4","value":"76.6"}]}],"title":"CMR left ventricular end-systolic volume index (LVESVI)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"87.9","upperLimit":"97.2","value":"92.6"},{"groupId":"OG001","lowerLimit":"32.3","upperLimit":"55.4","value":"42.9"},{"groupId":"OG002","lowerLimit":"86.8","upperLimit":"94.7","value":"90.7"}]}],"title":"CMR left ventricular stroke volume index (LVSVI)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"43"}],"units":"Participants"}],"description":"Specificity is defined as the number of true negatives divided by the number of true negatives + number of false positives.\n\n* Myocardial dysfunction was defined as the occurrence of either clinical or subclinical cardiotoxicity.\n* 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.\n* In patients with LVEF \\< 53% at baseline, clinical cardiotoxicity was defined by a symptomatic drop in LVEF \\> 10% or a HF hospitalization.\n* 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","dispersionType":"95% Confidence Interval","groups":[{"description":"* After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \\>-10% or 9 or more segments \\>-17% for entrance into the study as the Higher Risk Group\n* The unblinded treatment arm will enhance patient management by augmenting standard of care with serial MyoStrain® monitoring of the impact of cancer therapy on myocardial function.\n* Higher Risk unblinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.\n* In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.","id":"OG000","title":"MyoStrain® Unblinded Treatment Arm"},{"description":"* After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \\>-10% or 9 or more segments \\>-17% for entrance into the study as the Higher Risk group\n* The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care\n* Higher Risk blinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit.\n* In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.","id":"OG001","title":"MyoStrain® Blinded Control Arm"},{"description":"* After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \\>-10% or 9 or more segments \\>-17% for entrance into the study as the Higher Risk Group.\n* After 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.","id":"OG002","title":"Combined MyoStrain® Control Arm and Treatment Arm"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Through 36 months","title":"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","type":"PRIMARY","unitOfMeasure":"percent specificity"}