Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Theodore Abraham, MD
Headshot of Theodore Abraham
Theodore Abraham

Description

Summary

In this study, the hypothesis being explored is that VO2Max and 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 wearable biosensors worn by study participants. This study will aim to collect development and validation data for a machine learning algorithm and to evaluate the performance of the algorithm. A total of 500 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 400 participants.

Keywords

Cardiopulmonary

Eligibility

You can join if…

Open to people ages 18 years and up

  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) as Standard of Care

You CAN'T join if...

  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.

Locations

  • UCSF accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • VA Palo Alto Healthcare System accepting new patients
    Palo Alto 5380748 California 5332921 94304 United States

Lead Scientist at UCSF

  • Theodore Abraham, MD
    My are echocardiography and hypertrophic cardiomyopathy (HCM). I direct the UCSF Echocardiography laboratory and co-direct the UCSF HCM Center of Excellence. I have expertise in transthoracic, stress and transesophageal echocardiography. I also have training and expertise in 3D and strain echocardiography.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Prolaio
ID
NCT05678530
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated