Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
Start Date
6/6/2019
Completion Date
12/31/2027
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
Age Range: 18 years to No maximum
Conditions
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
VA Palo Alto Healthcare System
Palo Alto, California 94304
United States
University of California San Francisco
San Francisco, California 94143
United States
The Lundquist Institute
Torrance, California 90502
United States
Nemours Cardiac Center
Wilmington, Delaware 19803
United States
Memorial Healthcare System, Office of Human Research
Hollywood, Florida 33021
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
New Generation of Medical Research
Naples, Florida 34116
United States
physIQ
Chicago, Illinois 60606
United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois 60608
United States
Advocate Aurora Health Institute
Oakbrook Terrace, Illinois 60181
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Baylor Scott & White Research Institute
Dallas, Texas 75246
United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas 75093
United States
Intermountain Medical Center
Murray, Utah 84107
United States
Eastern Health Cardiac Rehabilitation
St. John's, Newfoundland and Labrador A1N3J5
Canada