WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG
研究概览
简要总结
The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •ability to understand study procedures and being willing to comply with them for the entire study length
- •diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy
排除标准
- •LVEF <50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm
- •Unwilling or unable to give written informed consent
- •Participants who have opted out of the Minnesota Research Authorization
研究组 & 干预措施
Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
干预措施: Electrocardiogram (Procedure)
Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
干预措施: Echocardiogram (Procedure)
Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
干预措施: LVEF echocardiogram (Procedure)
Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
干预措施: Biospecimen collection (Procedure)
Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
干预措施: Questionnaires (Other)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Electrocardiogram (Procedure)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Echocardiogram (Procedure)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: LVEF echocardiogram (Procedure)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Apple Watch (Other)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Biospecimen collection (Procedure)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Questionnaires (Other)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Cardio-pulmonary exercise test (Other)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: 6 minute walk test (Other)
Longitudinal Arm
Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
干预措施: Grip strength test (Other)
结局指标
主要结局
Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG
时间窗: Baseline to 1 year follow-up
Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF \<50%).
Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs
时间窗: Baseline to 1 year follow-up
The change in probability of abnormal LVEF by AI-ECG using mobile device ECG will be compared between patients who do develop a reduction in LVEF over time versus those who do not.
Change in peak VO2
时间窗: Baseline to 1 year follow-up
Volume of Oxygen (VO2) will be estimated by the Apple Watch algorithm (developed by Apple Inc.) and reviewed for change from baseline to 1 year.
次要结局
未报告次要终点
研究者
Joerg Herrmann, MD
Principal Investigator
Mayo Clinic