An Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 31
- 主要终点
- Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
研究概览
简要总结
In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using FDA-cleared wearable biosensors worn by study participants. This study will aim to collect data using wearable biosensors from standard of care patients toward the development of an algorithm that can estimate peak VO2 (eVO2peak) from biosensor data. In addition, this study will explore to further develop other estimated measurements typically reported in CPET, such as VE/VCO2 slope, as well as selected and measures of Left Ventricular Function (diastolic and systolic) typically reported in echocardiogram; instead using wearable biosensors from standard of care testing. A total of 2000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 1900 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with protocol procedures and available for the duration of the study.
- •Willing to sign and date informed consent document for study participation.
- •Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
排除标准
- •Participant is pregnant, lactating or ≤30 days post-partum.
- •Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).
- •If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded.
- •Barostim (™) or similar noncardiac electrical pulse generating device in situ.
- •Complex congenital heart disease (even repaired or palliated) with the following exception:
- •Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator.
- •Any history of allergy to adhesive
- •Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0, or perform a maximal CPET in the judgement of the investigator, and/or any limitations pertaining to obtaining a complete Echo
研究组 & 干预措施
Healthy
Healthy Subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care
Standard of Care
Standard of Care subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care
结局指标
主要结局
Collect development and validation data for a VO2Max (eVO2Max) machine learning algorithm and to evaluate the performance of the algorithm.
时间窗: March 2025
Develop an Estimated VO2Max (eVO2Max) algorithm which will estimate a participant's VO2Max value using data collected from physiological wearable biosensors (ECG \& Activity).
Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm.
时间窗: From enrollment to the end of collection at 7 days
Develop an Estimated Peak VO2 (eVO2peak) algorithm which will estimate a participant's peak VO2 value using data collected from physiological wearable biosensors (ECG \& Activity).
次要结局
- Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors(From enrollment to the end of collection at 7 days)