TriangleNCT03862131 · OUTCOME
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
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent specificity
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Through 36 months
What was measured
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
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 | Source count |
|---|---|
| MyoStrain® Unblinded Treatment Arm | 25 |
| MyoStrain® Blinded Control Arm | 18 |
| Combined MyoStrain® Control Arm and Treatment Arm | 43 |
Reported measurements
MyoStrain®
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 77.9 | Not reported | 70.5 | 85.2 | Not reported |
| MyoStrain® Blinded Control Arm | 88.4 | Not reported | 81.6 | 95.1 | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 73.6 | Not reported | 67.6 | 79.6 | Not reported |
CMR LVEF
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 95.0 | Not reported | 91.2 | 98.9 | Not reported |
| MyoStrain® Blinded Control Arm | 90.5 | Not reported | 84.2 | 96.8 | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 86.3 | Not reported | 81.6 | 91.0 | Not reported |
CMR left ventricular end-diastolic indexed (LVEDVI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 75.2 | Not reported | 67.5 | 82.9 | Not reported |
| MyoStrain® Blinded Control Arm | 52.4 | Not reported | 41.7 | 63.1 | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 61.5 | Not reported | 54.8 | 68.1 | Not reported |
CMR left ventricular end-systolic volume index (LVESVI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 99.2 | Not reported | 97.6 | 100.0 | Not reported |
| MyoStrain® Blinded Control Arm | 69.0 | Not reported | 59.2 | 78.9 | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 76.6 | Not reported | 70.8 | 82.4 | Not reported |
CMR left ventricular stroke volume index (LVSVI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 92.6 | Not reported | 87.9 | 97.2 | Not reported |
| MyoStrain® Blinded Control Arm | 42.9 | Not reported | 32.3 | 55.4 | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 90.7 | Not reported | 86.8 | 94.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.5
- upper Limit
- 85.2
- value
- 77.9
- group Id
- OG001
- lower Limit
- 81.6
- upper Limit
- 95.1
- value
- 88.4
- group Id
- OG002
- lower Limit
- 67.6
- upper Limit
- 79.6
- value
- 73.6
- title
- MyoStrain®
- categories
- measurements
- group Id
- OG000
- lower Limit
- 91.2
- upper Limit
- 98.9
- value
- 95.0
- group Id
- OG001
- lower Limit
- 84.2
- upper Limit
- 96.8
- value
- 90.5
- group Id
- OG002
- lower Limit
- 81.6
- upper Limit
- 91.0
- value
- 86.3
- title
- CMR LVEF
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.5
- upper Limit
- 82.9
- value
- 75.2
- group Id
- OG001
- lower Limit
- 41.7
- upper Limit
- 63.1
- value
- 52.4
- group Id
- OG002
- lower Limit
- 54.8
- upper Limit
- 68.1
- value
- 61.5
- title
- CMR left ventricular end-diastolic indexed (LVEDVI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 97.6
- upper Limit
- 100.0
- value
- 99.2
- group Id
- OG001
- lower Limit
- 59.2
- upper Limit
- 78.9
- value
- 69.0
- group Id
- OG002
- lower Limit
- 70.8
- upper Limit
- 82.4
- value
- 76.6
- title
- CMR left ventricular end-systolic volume index (LVESVI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 87.9
- upper Limit
- 97.2
- value
- 92.6
- group Id
- OG001
- lower Limit
- 32.3
- upper Limit
- 55.4
- value
- 42.9
- group Id
- OG002
- lower Limit
- 86.8
- upper Limit
- 94.7
- value
- 90.7
- title
- CMR left ventricular stroke volume index (LVSVI)
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 18
- group Id
- 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. * 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
- 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
- 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
- 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
- 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
- unit Of Measure
- percent specificity
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Preserved source evidence · Not medical advice