Breast Cancer, Cancer, Cardiac Arrhythmia, Cardiotoxicity, Left Ventricular Dysfunction, Multiple Myeloma
Conditions
Keywords
MCT-WAVE, Mobile cardiac telemetry, Wearable cardiac monitor, Cardio-oncology, Ventricular arrhythmia, Breast cancer
Brief summary
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.
Detailed description
Cancer patients may develop cardiovascular complications during cancer treatment, including cardiac arrhythmias, cardiac dysfunction, hypertension, heart failure, and other cardiotoxic effects. Early recognition of cardiotoxicity may help inform monitoring strategies and clinical management during and after cancer treatment. MCT-WAVE is a prospective, single-arm exploratory pilot study enrolling adults with breast cancer, hematologic malignancy, or multiple myeloma. Each participant will receive usual care plus two wearable patch-based cardiac monitoring devices. Mobile cardiac telemetry will be performed using the FDA-cleared Preventice BodyGuardian Mini Plus ambulatory ECG monitor to collect continuous heart rhythm data. A wearable cardiac monitor patch will also be used to record heart sounds using an accelerometer. Data from the wearable cardiac monitor will be collected for offline analysis and will not be used to guide clinical decision-making in this study. Participants will be screened for eligibility and, after informed consent, will be fitted with the wearable devices. Baseline data will be collected through electronic medical record review, including demographics, medical history, laboratory values, EKG results, echocardiogram results, medications, cancer treatment information, and clinical events. Participants will receive instructions on how to use and return the devices. The mobile cardiac telemetry device will be worn for 14 consecutive days and will collect near-real-time ECG data. The wearable cardiac monitor will also be worn for 14 days and will collect heart sounds data. Additional device placement may occur at the 6-month and 12-month study visits. Participants will continue to receive all standard-of-care cancer treatment and cardiac monitoring as determined by their clinical care team. The primary outcome is incident atrial or ventricular arrhythmia detected during the study. Secondary outcomes include the association between heart sounds and echocardiographic findings of systolic or diastolic dysfunction, and the association between heart sounds and cardiac laboratory markers such as high-sensitivity troponin I and NT-proBNP.
Interventions
DEVICEMobile Cardiac Telemetry
Participants 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.
DEVICEWearable Cardiac Monitor
Participants 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.
Sponsors
University of Minnesota
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Known allergy to adhesive patches used for ambulatory EKG monitoring * Children * Cognitively challenged individuals * Prisoners * Active service military personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident Atrial or Ventricular Arrhythmia | Up to 12 months | Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | 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 | Up to 12 months | Correlation between heart sound measures collected by the wearable cardiac monitor and echocardiographic measures of diastolic function during the study period. |
Countries
United States
Contacts
CONTACTSuma Konety, MD
CONTACTSamantha Wansing
PRINCIPAL_INVESTIGATORSuma Konety, MD
University of Minnesota
Outcome results
None listed