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Multimodal Physiologic State Intelligence Study

Enrolling By InvitationN/A

Sponsor: Truway Health, Inc.

Conditions: Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute, Myocarditis Due to Drug

Interventions: OMNIPHYS Multimodal Ultrasound Imaging System

Countries: United States

The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state over time. The study will examine cardiac, vascular, pulmonary, and systemic physiologic measurements and develop longitudinal models that describe baseline physiology, physiologic perturbation, compensation, deterioration, treatment response, and recovery. The study is observational and will not assign experimental treatments. The goal is to determine whether changes in multimodal physiologic patterns can be identified and characterized earlier and more reliably than conventional single-time-point assessment.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 years or older who are capable of providing informed consent, or who meet applicable legally authorized representative requirements where permitted.
2. Individuals undergoing routine clinical evaluation, diagnostic imaging, monitoring, treatment, or longitudinal follow-up, including individuals with relevant cardiovascular, vascular, pulmonary, renal, systemic, or other conditions represented within the OMNIPHYS research framework.
3. Healthy volunteers without the conditions under study may participate as reference participants.
4. Ability to undergo at least one protocol-relevant physiologic or imaging assessment and/or contribute eligible routinely collected clinical data.
5. Availability of sufficient clinical, physiologic, imaging, or longitudinal outcome data for the applicable analysis.
6. Willingness to permit collection and longitudinal analysis of protocol-defined research data in accordance with informed consent and applicable privacy and data-governance requirements.

Exclusion Criteria:

1. Inability or unwillingness to provide informed consent or otherwise meet applicable consent requirements.
2. Inability to obtain interpretable protocol-relevant physiologic or imaging data when such data are required for the applicable analysis.
3. Conditions or circumstances that, in the judgment of the responsible clinical investigator, make participation inappropriate or prevent meaningful longitudinal follow-up.
4. Withdrawal of consent or request for discontinuation of research participation where applicable.
5. Any circumstance that would prevent collection, secure handling, or analysis of study data in accordance with the approved protocol and applicable requirements.

Locations (1)

New York, New York, United States