Clinical Research Directory

Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways

Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm monitoring. The study evaluates a clinician-facing, AI-enabled decision-support system that analyzes data from the Cor XT and Cor MDx wearable ECG devices and organizes patient-specific findings into an integrated Cor360 report for review by qualified clinicians. Rather than focusing only on detection of arrhythmias, Cor360 evaluates multiple dimensions of cardiovascular physiology and disease simultaneously. The active Cor360 indication panel may include more than 150 reportable findings or sub-findings organized across six clinically oriented pathways: Structural, Functional, Conductance, Hemodynamic, Neurohormonal/Autonomic, and Atrial Fibrillation/Ventricular Arrhythmia/Sudden Cardiac Death. Depending on the ECG data available for an individual participant, Cor360 may characterize findings and risk markers related to left ventricular hypertrophy and atrial enlargement; heart-failure phenotype and ejection-fraction-related abnormalities; conduction delay and heart block; repolarization and ischemia-related abnormalities; atrial fibrillation and atrial substrate; ventricular ectopy, nonsustained ventricular tachycardia and electrical-instability markers; syncope mechanisms; and selected ECG-derived hemodynamic and structural/functional surrogates. The platform may also evaluate autonomic regulation and heart-rate variability, cardiopulmonary coupling, sleep-disordered breathing and obstructive sleep apnea screening indicators, electrolyte-related ECG abnormalities, and other clinically relevant physiologic patterns. Cor360 is designed to move from isolated ECG findings toward multidimensional cardiac phenotyping and multi-pathway risk assessment. Individual findings may be combined into clinically meaningful phenotypes and risk profiles, such as atrial-fibrillation-prone substrate, heart-failure-related autonomic or repolarization profiles, ventricular electrical-instability patterns, ischemia-related risk signals, or sleep-disordered-breathing-related cardiovascular burden. Where repeated ECG studies are available, Cor360 may also assess changes in cardiac phenotype, physiologic state, and risk trajectory over time. Reports are individualized rather than identical across participants. Only indications supported by the participant's available data, signal quality, monitoring duration, and applicable analysis criteria are presented. Longer-duration recordings may support deeper assessment of autonomic function, sleep-related physiology, intermittent abnormalities, and longitudinal risk patterns. Cor360 also evaluates whether an extended wearable ECG record can support cross-domain clinical synthesis rather than requiring each physiologic signal to be interpreted in isolation. When appropriate, reports may link detected phenotypes and risk markers to guideline-informed care-pathway considerations while identifying uncertainty, data-quality limitations, and findings that are not reportable because monitoring-duration or signal criteria are not met. The primary objective of the study is to determine whether clinicians judge Cor360 reports to provide clinically actionable cardiac phenotyping or risk-assessment information. The study will also evaluate whether reviewing a Cor360 report changes, refines, or confirms a clinician's assessment or intended care pathway, and how Cor360 findings agree with available clinical reference information, standard-of-care testing, or independent expert review. The study includes adults 18 years of age or older with completed or planned Cor XT or Cor MDx wearable ECG monitoring. It includes retrospective and prospective single-study assessments, longitudinal repeated-study assessments, combined retrospective/prospective analyses, and selected limited-duration streaming or patient-activated event assessments. The protocol spans real-world acquisition settings, including home, clinic, ambulatory care, emergency department/triage, ambulance or transport, hospital-based, and hybrid clinic-to-home workflows. Where suitable reference information is available, Cor360 findings may be compared with 12-lead ECG interpretation, Holter or ambulatory ECG findings, echocardiography, other imaging, laboratory results, sleep testing, clinical diagnosis, or blinded expert-panel review. Cor360 is being evaluated as a clinician-facing decision aid and not as an autonomous diagnostic system. Its outputs are intended to augment clinical interpretation and support consideration of relevant care pathways, including rhythm management, heart-failure evaluation, ischemia assessment, conduction or pacing evaluation, and sleep-apnea work-up. The clinician remains responsible for diagnosis, treatment, testing, referral, and patient management.

Effectiveness of a Wearable Hydration Device

Dehydration among older adults a costs billions of dollars in US healthcare every year because no robust solution exists to detect changes in hydration and prevent negative outcomes. In this project, TritonX Technologies Inc. and academic research partners plan to test whether a newly created wearable sensor that measures hydration in real time can promote hydration and prevent the dehydration illnesses. The investigators will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting. The goal of this randomized control trial is to examine the effectiveness of continuous home monitoring of fluid levels in older patients presenting to the emergency department for dehydration. The main questions it aims to answer: 1. Can a wearable device accurately determine the severity of dehydration at home and 2. can a wearable device and continuous feedback from the device change behavior in the outpatient setting that can lead to improved outcomes in the treatment of dehydration in the elderly? Investigators will compare device readings, hydration diaries, vital signs, blood samples, return visits to the emergency department, and to see if feedback from the device decreases signs and symptoms of dehydration and changes home management of dehydration. Participants will be asked to: * wear the device and monitor hydration status * record the amount of home hydration * return in 7-10 days for reassessment of dehydration The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.