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

Conditions

• Cardiopulmonary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

First listed

Jan 10, 2023

Start date

Jun 6, 2019

Status verified

Sep 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Healthy
  Healthy Subjects who undergo the CPET, or an ECHO, or both CPET and ECHO, as part of routine Standard of Care
• Arm: 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

Primary Outcome Measure

Collect development and validation data for a peak VO2 (eVO2peak) machine learning algorithm and to evaluate the performance of the algorithm. [ Time Frame: From enrollment to the end of collection at 7 days ]

Central Contacts

• Clinical Trials at Prolaio
  855-869-9054
  [email protected]

Locations (15)

Find similar trials in Scottsdale, AZ

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