This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.
Participants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers.
Participants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.
Diagnosis of breast cancer, hematologic malignancy including leukemia or lymphoma, or multiple myeloma
At least 18 years of age
Capable of understanding and willing to sign a consent form for this study
Known allergy to adhesive patches used for ambulatory EKG monitoring
Children
Cognitively challenged individuals
Prisoners
Single group
Mobile Cardiac Telemetry
DeviceParticipants will wear the FDA-cleared BodyGuardian Mini Plus mobile cardiac telemetry patch device for continuous ECG monitoring. The device will collect near-real-time heart rhythm data to identify arrhythmias during and following cancer treatment.
Wearable Cardiac Monitor
DeviceParticipants will wear an investigational non-significant risk wearable cardiac monitor patch that records heart sounds using an accelerometer. Data from the device will be used for offline analyses and will not be used for clinical decision-making in this study.
Incident Atrial or Ventricular Arrhythmia
Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed.
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I
Correlation between heart sound measures collected by the wearable cardiac monitor and high-sensitivity troponin I concentration during the study period.
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and NT-proBNP
Correlation between heart sound measures collected by the wearable cardiac monitor and NT-proBNP concentration during the study period.
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Left Ventricular Ejection Fraction
Correlation between heart sound measures collected by the wearable cardiac monitor and left ventricular ejection fraction measured by echocardiography during the study period.
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Echocardiographic Measures of Diastolic Function
Correlation between heart sound measures collected by the wearable cardiac monitor and echocardiographic measures of diastolic function during the study period.
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University of Minnesota
Lead sponsor
Boston Scientific Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
