NCT05678530 Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
| NCT ID | NCT05678530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prolaio |
| Condition | Cardiopulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2019-06-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2019-06-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Greg Kurio, MD
STUDY DIRECTOR
Prolaio, Inc
Frequently Asked Questions
Who can join the NCT05678530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiopulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05678530 currently recruiting?
Yes, NCT05678530 is actively recruiting participants. Contact the research team at hello@prolaio.com for enrollment information.
Where is the NCT05678530 trial being conducted?
This trial is being conducted at Scottsdale, United States, Palo Alto, United States, San Francisco, United States, Torrance, United States and 11 additional locations.
Who is sponsoring the NCT05678530 clinical trial?
NCT05678530 is sponsored by Prolaio. The principal investigator is Greg Kurio, MD at Prolaio, Inc. The trial plans to enroll 2,000 participants.