Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProlaio

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Participant is pregnant, lactating or ≤30 days post-partum.

Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing).

Barostim (™) or similar noncardiac electrical pulse generating device in situ.

Any history of allergy to adhesive

Trial population

Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 2 trial groups
Group A: Healthy
Group B: Standard of Care

Trial outcomes

Primary outcomes

1

Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm.

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).

Time frame
From enrollment to the end of collection at 7 days

Secondary outcomes

1

Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors

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.

Time frame
From enrollment to the end of collection at 7 days

Other outcomes

Sponsors and contacts

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