Breast Cancer, Cardiotoxicity, Leukemia, Lung Cancer, Lymphoma, Myeloma, Sarcoma
Conditions
Brief summary
This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.
Detailed description
The primary purpose of the PROACT study is to test the accuracy of MyoStrain® to detect cardiotoxicity in patients on high risk cancer therapy. After undergoing baseline MRI and 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.
Interventions
DEVICEMyoStrain®
MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
Sponsors
Myocardial Solutions
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients will be classified based on baseline segmental MyoStrain Fast-SENC strain testing, into lower and higher risk groups. The higher risk group will be randomized with half blinded and half unblinded to intramyocardial strain in terms of assessing cardiotoxicity incidence and management. Physicians will have knowledge of MyoStrain intramyocardial strain and cardiac MRI information in the unblinded group to augment standard of care in detecting and managing cardiotoxicity. Physicians will not have access to or knowledge of intramyocardial strain and cardiac MRI data, except 4 standard cardiac measures, for patients in the blinded group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant in the SURVIVE registry * Signed informed consent form for PROACT * Histological diagnosis of any cancer type (patients with treated and clinically stable brain metastasis are acceptable) * Scheduled to receive anti-cancer therapy (radiation therapy is permitted)
Exclusion criteria
* Contraindication to magnetic resonance imaging (MRI) * Unable to comply with study investigations (in the judgment of the investigator) * Life expectancy less than 1 year * Note: If a patient develops a temporary contraindication (e.g. temporary tissue expanders in breast cancer patients) after the baseline MRI, follow up MRIs will be discontinued for safety for the duration in which the patient has the contraindication. However, once the patient is no longer contraindicated to receiving MRIs, the study schedule may resume with their next scheduled MRI time point from the date of enrollment. Therefore, some time points may be skipped during the patient's enrollment in the study. Also, if a patient needs a repeat MRI at any time point for any reason (i.e. panic attack during the MRI causing them to not be able to continue, unreadable images, etc.), we may repeat the MRI as long as the patient is willing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through 36 months | 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. |
| Sensitivity of MyoStrain® Compared to 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 | Through 36 months | Sensitivity is defined as the number of true positives divided by the number of true positives + number of false negatives. * 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 |
| 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 | Through 36 months | 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 |
| Accuracy 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 | Through 36 months | Accuracy is defined as (true positives + true negatives) divided by the total number of cases * 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. |
| Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Through 36 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 18 |
| Non-randomized -Patients were enrolled but not randomized to either arm. | 6 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 4 | 0 |
| Overall Study | Determined to be ineligible | 0 | 0 | 5 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 0 |
Baseline characteristics
| Characteristic | MyoStrain® Unblinded Treatment Arm | Total | Non-randomized | MyoStrain® Blinded Control Arm |
|---|---|---|---|---|
| Age, Continuous | 55 years | 55 years | 48.5 years | 58.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 48 Participants | 6 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 44 Participants | 5 Participants | 18 Participants |
| Region of Enrollment United States | 25 participants | 49 participants | 6 participants | 18 participants |
| Sex: Female, Male Female | 20 Participants | 36 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 25 | 4 / 18 | 0 / 6 |
| other Total, other adverse events | 1 / 25 | 1 / 18 | 0 / 6 |
| serious Total, serious adverse events | 0 / 25 | 0 / 18 | 0 / 6 |
Outcome results
Primary
Accuracy 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
Accuracy is defined as (true positives + true negatives) divided by the total number of cases * 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.
Time frame: Through 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | Accuracy 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 | CMR left ventricular stroke volume index (LVSVI) | 84.9 percent accuracy |
| MyoStrain® Unblinded Treatment Arm | Accuracy 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 | MyoStrain® | 78.6 percent accuracy |
| MyoStrain® Unblinded Treatment Arm | Accuracy 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 | CMR LVEF | 87.1 percent accuracy |
| MyoStrain® Unblinded Treatment Arm | Accuracy 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 71.2 percent accuracy |
| MyoStrain® Unblinded Treatment Arm | Accuracy 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 | CMR left ventricular end-systolic volume index (LVESVI) | 89.2 percent accuracy |
| MyoStrain® Blinded Control Arm | Accuracy 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 | MyoStrain® | 85.1 percent accuracy |
| MyoStrain® Blinded Control Arm | Accuracy 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 | CMR LVEF | 84.8 percent accuracy |
| MyoStrain® Blinded Control Arm | Accuracy 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 | CMR left ventricular end-systolic volume index (LVESVI) | 68.7 percent accuracy |
| MyoStrain® Blinded Control Arm | Accuracy 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 | CMR left ventricular stroke volume index (LVSVI) | 50.5 percent accuracy |
| MyoStrain® Blinded Control Arm | Accuracy 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 54.5 percent accuracy |
| Combined MyoStrain® Control Arm and Treatment Arm | Accuracy 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 59.7 percent accuracy |
| Combined MyoStrain® Control Arm and Treatment Arm | Accuracy 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 | CMR left ventricular end-systolic volume index (LVESVI) | 72.3 percent accuracy |
| Combined MyoStrain® Control Arm and Treatment Arm | Accuracy 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 | CMR left ventricular stroke volume index (LVSVI) | 82.8 percent accuracy |
| Combined MyoStrain® Control Arm and Treatment Arm | Accuracy 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 | CMR LVEF | 80.3 percent accuracy |
| Combined MyoStrain® Control Arm and Treatment Arm | Accuracy 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 | MyoStrain® | 75.1 percent accuracy |
Primary
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures
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
Time frame: Through 36 months
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Clinical events | 7 myocardial dysfunction events |
| MyoStrain® Unblinded Treatment Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Subclinical events | 10 myocardial dysfunction events |
| MyoStrain® Blinded Control Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Clinical events | 7 myocardial dysfunction events |
| MyoStrain® Blinded Control Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Subclinical events | 8 myocardial dysfunction events |
| Combined MyoStrain® Control Arm and Treatment Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Clinical events | 14 myocardial dysfunction events |
| Combined MyoStrain® Control Arm and Treatment Arm | Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging Measures | Subclinical events | 18 myocardial dysfunction events |
Primary
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
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.
Time frame: Through 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 0.574 probability |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR LVEF | 0.603 probability |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 0.522 probability |
| MyoStrain® Unblinded Treatment Arm | 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 | MyoStrain® | 0.876 probability |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 0.501 probability |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 0.693 probability |
| MyoStrain® Blinded Control Arm | 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 | MyoStrain® | 0.853 probability |
| MyoStrain® Blinded Control Arm | 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 | CMR LVEF | 0.790 probability |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 0.532 probability |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 0.689 probability |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 0.627 probability |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 0.515 probability |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | MyoStrain® | 0.864 probability |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 0.589 probability |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR LVEF | 0.679 probability |
Primary
Sensitivity of MyoStrain® Compared to 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
Sensitivity is defined as the number of true positives divided by the number of true positives + number of false negatives. * 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
Time frame: Through 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-systolic volume index (LVESVI) | 22.2 percent sensitivity |
| MyoStrain® Unblinded Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 44.4 percent sensitivity |
| MyoStrain® Unblinded Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR LVEF | 33.3 percent sensitivity |
| MyoStrain® Unblinded Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | MyoStrain® | 83.3 percent sensitivity |
| MyoStrain® Unblinded Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular stroke volume index (LVSVI) | 33.3 percent sensitivity |
| MyoStrain® Blinded Control Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 66.7 percent sensitivity |
| MyoStrain® Blinded Control Arm | Sensitivity of MyoStrain® Compared to 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 | CMR LVEF | 53.3 percent sensitivity |
| MyoStrain® Blinded Control Arm | Sensitivity of MyoStrain® Compared to 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 | MyoStrain® | 66.7 percent sensitivity |
| MyoStrain® Blinded Control Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-systolic volume index (LVESVI) | 66.7 percent sensitivity |
| MyoStrain® Blinded Control Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular stroke volume index (LVSVI) | 93.3 percent sensitivity |
| Combined MyoStrain® Control Arm and Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular stroke volume index (LVSVI) | 33.3 percent sensitivity |
| Combined MyoStrain® Control Arm and Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-systolic volume index (LVESVI) | 45.5 percent sensitivity |
| Combined MyoStrain® Control Arm and Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | MyoStrain® | 84.8 percent sensitivity |
| Combined MyoStrain® Control Arm and Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 48.5 percent sensitivity |
| Combined MyoStrain® Control Arm and Treatment Arm | Sensitivity of MyoStrain® Compared to 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 | CMR LVEF | 42.4 percent sensitivity |
Primary
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
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
Time frame: Through 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 92.6 percent specificity |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 99.2 percent specificity |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR LVEF | 95.0 percent specificity |
| MyoStrain® Unblinded Treatment Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 75.2 percent specificity |
| MyoStrain® Unblinded Treatment Arm | 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 | MyoStrain® | 77.9 percent specificity |
| MyoStrain® Blinded Control Arm | 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 | CMR LVEF | 90.5 percent specificity |
| MyoStrain® Blinded Control Arm | 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 | MyoStrain® | 88.4 percent specificity |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 52.4 percent specificity |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 69.0 percent specificity |
| MyoStrain® Blinded Control Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 42.9 percent specificity |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular end-diastolic indexed (LVEDVI) | 61.5 percent specificity |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | MyoStrain® | 73.6 percent specificity |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular end-systolic volume index (LVESVI) | 76.6 percent specificity |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR LVEF | 86.3 percent specificity |
| Combined MyoStrain® Control Arm and Treatment Arm | 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 | CMR left ventricular stroke volume index (LVSVI) | 90.7 percent specificity |