TriangleNCT03862131 · OUTCOME
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- myocardial dysfunction events
- Interval / dispersion
- Not reported
- Time frame
- Through 36 months
What was measured
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
Analysis population: 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).
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 | 8 |
| MyoStrain® Blinded Control Arm | 10 |
| Combined MyoStrain® Control Arm and Treatment Arm | 18 |
Reported measurements
Clinical events
| Group | Source count |
|---|---|
| MyoStrain® Unblinded Treatment Arm | 4 |
| MyoStrain® Blinded Control Arm | 6 |
| Combined MyoStrain® Control Arm and Treatment Arm | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 7 | Not reported | Not reported | Not reported | Not reported |
| MyoStrain® Blinded Control Arm | 7 | Not reported | Not reported | Not reported | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 14 | Not reported | Not reported | Not reported | Not reported |
Subclinical events
| Group | Source count |
|---|---|
| MyoStrain® Unblinded Treatment Arm | 7 |
| MyoStrain® Blinded Control Arm | 6 |
| Combined MyoStrain® Control Arm and Treatment Arm | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 10 | Not reported | Not reported | Not reported | Not reported |
| MyoStrain® Blinded Control Arm | 8 | Not reported | Not reported | Not reported | Not reported |
| Combined MyoStrain® Control Arm and Treatment Arm | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 10
- units
- Participants
- title
- Clinical events
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 18
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Subclinical events
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- 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
- 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
- population Description
- 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).
- reporting Status
- POSTED
- time Frame
- Through 36 months
- title
- Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
- type
- PRIMARY
- unit Of Measure
- myocardial dysfunction events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice