{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"}],"units":"Participants"}],"title":"Clinical events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"13"}],"units":"Participants"}],"title":"Subclinical events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"18"}],"units":"Participants"}],"description":"Myocardial dysfunction is the occurrence of either clinical or subclinical cardiotoxicity.\n\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","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","populationDescription":"Events were excluded if there was an earlier event in the same patient closer in time to the MRI scan (6 events). Events were also excluded if they were \\> 6 months from the last MRI scan (1 event).","reportingStatus":"POSTED","timeFrame":"Through 36 months","title":"Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures","type":"PRIMARY","unitOfMeasure":"myocardial dysfunction events"}