Cardiopulmonary
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Prolaio
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to comply with protocol procedures and available for the duration of the study. 2. Willing to sign and date informed consent document for study participation. 3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care
Exclusion criteria
1. Participant is pregnant, lactating or ≤30 days post-partum. 2. 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. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ. 4. 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. 5. Any history of allergy to adhesive 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Further develop other estimated measurements typically reported in CPET and echocardiogram using wearable biosensors | From enrollment to the end of collection at 7 days | 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. |
Countries
Canada, United States
Contacts
CONTACTClinical Trials at Prolaio
STUDY_DIRECTORGreg Kurio, MD
Prolaio, Inc
Outcome results
None listed