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Enrolling By Invitation
NCT07814118
Multimodal Physiologic State Intelligence Study
Conditions: Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute, Myocarditis Due to Drug, Myocarditis Viral, Pericardial Diseases, Valvular Heart Diseases, Hypertension, Sepsis, Acute Kidney Injury, Pulmonary Edema - Acute, Pulmonary Edema With Heart Failure, Pulmonary Edemas, Acute Respiratory Distress Syndrome, Pulmonary Embolism Acute, Pulmonary Embolism (Diagnosis), Pulmonary Embolism Acute Massive, Pulmonary Embolism Subacute Massive, Venous Thrombosis Pulmonary, Venous Thrombosis (Disorder), Venous Thrombosis, Deep, Peripheral Arterial Disease, Peripheral Arterial Disease (PAD), Aortic Diseases, Muskuloskeletal Diseases, Brain Aging, Brain Aneurysm, Brain Aging Related Conditions, Ultrasound, Ultrasound Exams, Ultrasound Guidance
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 25000
Sponsor: Truway Health, Inc.
Location: Truway Health, Inc. New York New York
Summary
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 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.
Source: ClinicalTrials.gov (NCT07814118). StuddyBuddy aggregates publicly available trial information.
