Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incident Atrial or Ventricular Arrhythmia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known allergy to adhesive patches used for ambulatory EKG monitoring
- •Cognitively challenged individuals
- •Prisoners
- •Active service military personnel
研究组 & 干预措施
Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care
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.
干预措施: Mobile Cardiac Telemetry (Device)
Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care
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.
干预措施: Wearable Cardiac Monitor (Device)
结局指标
主要结局
Incident Atrial or Ventricular Arrhythmia
时间窗: Up to 12 months
Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed.
次要结局
- Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I(Up to 12 months)
- Correlation Between Wearable Cardiac Monitor Heart Sound Measures and NT-proBNP(Up to 12 months)
- Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Left Ventricular Ejection Fraction(Up to 12 months)
- Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Echocardiographic Measures of Diastolic Function(Up to 12 months)