Wearable Devices for Cardiotoxicity Monitoring in Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Suma Konety, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults with breast cancer, blood cancers, or multiple myeloma who are starting or undergoing cancer treatment. Participants must be able to wear heart monitoring devices during their therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Monitoring
Participants are fitted with wearable devices and baseline data is collected
Cancer Treatment Monitoring
Participants wear devices during cancer treatment to monitor cardiac function
Follow-up Monitoring
Additional device placement and monitoring at 6-month and 12-month visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests if wearable heart monitors can safely and effectively detect early signs of heart problems in people receiving cancer treatments. Participants will use two types of patch monitors at different times during their care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with cancer will receive usual care plus mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and a wearable cardiac monitor patch to collect heart sounds. Devices will be worn during cancer treatment to collect arrhythmia and cardiac function monitoring data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
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