Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
University of Minnesota
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
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.
Location
- M Health Fairview Clinics and Surgery CenterMinneapolis, Minnesota