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NCT03862131 · OUTCOME

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

PROactive Evaluation of Function to Avoid CardioToxicity · Source last updated 2025-07-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
probability
Interval / dispersion
95% Confidence Interval
Time frame
Through 36 months

What was measured

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.

Groups in this outcome

MyoStrain® Unblinded Treatment Arm

* 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 * 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. * 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. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.

MyoStrain® Blinded Control Arm

* 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 * The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care * 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. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.

Combined MyoStrain® Control Arm and Treatment Arm

* 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. * 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MyoStrain® Unblinded Treatment Arm25
MyoStrain® Blinded Control Arm18
Combined MyoStrain® Control Arm and Treatment Arm43

Reported measurements

MyoStrain®
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MyoStrain® Unblinded Treatment Arm0.876Not reported0.7700.982Not reported
MyoStrain® Blinded Control Arm0.853Not reported0.7280.978Not reported
Combined MyoStrain® Control Arm and Treatment Arm0.864Not reported0.7830.946Not reported
CMR LVEF
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MyoStrain® Unblinded Treatment Arm0.603Not reported0.4560.749Not reported
MyoStrain® Blinded Control Arm0.790Not reported0.6480.933Not reported
Combined MyoStrain® Control Arm and Treatment Arm0.679Not reported0.5730.786Not reported
CMR left ventricular end-diastolic indexed (LVEDVI)
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MyoStrain® Unblinded Treatment Arm0.522Not reported0.3770.666Not reported
MyoStrain® Blinded Control Arm0.532Not reported0.3700.693Not reported
Combined MyoStrain® Control Arm and Treatment Arm0.515Not reported0.4080.622Not reported
CMR left ventricular end-systolic volume index (LVESVI)
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MyoStrain® Unblinded Treatment Arm0.501Not reported0.3580.645Not reported
MyoStrain® Blinded Control Arm0.689Not reported0.5310.847Not reported
Combined MyoStrain® Control Arm and Treatment Arm0.589Not reported0.4810.698Not reported
CMR left ventricular stroke volume index (LVSVI)
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MyoStrain® Unblinded Treatment Arm0.574Not reported0.4280.721Not reported
MyoStrain® Blinded Control Arm0.693Not reported0.5350.850Not reported
Combined MyoStrain® Control Arm and Treatment Arm0.627Not reported0.5190.735Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.770
        upper Limit
        0.982
        value
        0.876
      2. group Id
        OG001
        lower Limit
        0.728
        upper Limit
        0.978
        value
        0.853
      3. group Id
        OG002
        lower Limit
        0.783
        upper Limit
        0.946
        value
        0.864
    title
    MyoStrain®
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.456
        upper Limit
        0.749
        value
        0.603
      2. group Id
        OG001
        lower Limit
        0.648
        upper Limit
        0.933
        value
        0.790
      3. group Id
        OG002
        lower Limit
        0.573
        upper Limit
        0.786
        value
        0.679
    title
    CMR LVEF
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.377
        upper Limit
        0.666
        value
        0.522
      2. group Id
        OG001
        lower Limit
        0.370
        upper Limit
        0.693
        value
        0.532
      3. group Id
        OG002
        lower Limit
        0.408
        upper Limit
        0.622
        value
        0.515
    title
    CMR left ventricular end-diastolic indexed (LVEDVI)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.358
        upper Limit
        0.645
        value
        0.501
      2. group Id
        OG001
        lower Limit
        0.531
        upper Limit
        0.847
        value
        0.689
      3. group Id
        OG002
        lower Limit
        0.481
        upper Limit
        0.698
        value
        0.589
    title
    CMR left ventricular end-systolic volume index (LVESVI)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.428
        upper Limit
        0.721
        value
        0.574
      2. group Id
        OG001
        lower Limit
        0.535
        upper Limit
        0.850
        value
        0.693
      3. group Id
        OG002
        lower Limit
        0.519
        upper Limit
        0.735
        value
        0.627
    title
    CMR left ventricular stroke volume index (LVSVI)
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      43
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. 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 * 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. * 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. * 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
  2. 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 * The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care * 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. * 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
  3. 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. * 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
param Type
NUMBER
reporting Status
POSTED
time Frame
Through 36 months
title
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
type
PRIMARY
unit Of Measure
probability

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Preserved source evidence · Not medical advice