Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-06

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 1000 participants will be enrolled including: (Normal) 100 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 900 participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiopulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

Healthy Subjects who undergo the CPET

No interventions assigned to this group

Standard of Care

Standard of Care subjects who undergo the CPET as part of routine Standard of Care

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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) 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Greg Kurio, MD

Role: STUDY_DIRECTOR

Prolaio, Inc

Review additional registry numbers or institutional identifiers associated with this trial.

CTP-020

Identifier Type: -

Identifier Source: org_study_id

Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Healthy

Standard of Care

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Prolaio

Responsible Party

Principal Investigators

Greg Kurio, MD

Locations

Mayo Clinic Arizona

VA Palo Alto Healthcare System

University of California San Francisco

The Lundquist Institute

Nemours Cardiac Center

Memorial Healthcare System, Office of Human Research

Mayo Clinic Florida

New Generation of Medical Research

physIQ

University of Illinois Hospital & Health Sciences System

Advocate Aurora Health Institute

Mayo Clinic

Baylor Scott & White Research Institute

Baylor Scott & White The Heart Hospital - Plano

Intermountain Medical Center

Eastern Health Cardiac Rehabilitation

Countries

Central Contacts

Clinical Trials at Prolaio

Facility Contacts

Research Technologist

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Trial Project Manager

Research Coordinator

Research Program Manager

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Research Coordinator

Dr. Cemal Ozemek

Research Technologist

Research Enrollment Analyst

Supervisor Clinical Research

Project Coordinator, Outpatient Pulmonary Research

Clinical Research Coordinator

Other Identifiers

CTP-020