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PROactive Evaluation of Function to Avoid CardioToxicity

Phase 2
Terminated
Conditions
Cardiotoxicity
Lymphoma
Lung Cancer
Leukemia
Breast Cancer
Sarcoma
Myeloma
Registration Number
NCT03862131
Lead Sponsor
Washington University School of Medicine
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
49
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Independent Effectiveness of MyoStrain® to Detect Cardiac Dysfunction Compared to Standard Cardiac Imaging MeasuresThrough 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

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 TreatmentThrough 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 TreatmentThrough 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 TreatmentThrough 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 TreatmentThrough 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States

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