COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable

NCT06763549 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: PBH-COR-INSIGHT-1PBH-COR-INSIGHT-1-A
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.

Conditions

Cardiopulmonary Failure; Myocardial Infarction (MI); Heart Decompensation; Heart Failure; HFrEF - Heart Failure with Reduced Ejection Fraction; HFpEF - Heart Failure with Preserved Ejection Fraction; Syncopation; Syncope; Ischemic Cardiovascular Disease; STEMI; STEMI (ST Elevation MI); Atrial Fibrillation (AF); Atrial Enlargement; LVF; Conduction Defect; Conduction Abnormalities; Heart Block; Valvular Diseases; Cardiac Output, Low; Stroke Volume; Stroke Volume Variation; Hyperkalemia; Hypercalcemia; Hypocalcemia; LV Dysfunction; QT Prolongation; Sudden Cardiac Death Due to Cardiac Arrhythmia; Ventricular Arrhythmia; Pacing; Pacing Induced Dyssynchrony; Silent Ischemia; Pericarditis; Sleep Related Breathing Disorder; RSA; Apnea, Obstructive; Cardiac Output Measurement; Respiratory Impedance; CRT And/or ICD; Infarction; Cardiomyopathies, Primary; Hypertrophy

Keywords

CORMDX; COR; Peerbridge COR; CardioMIND; CardioQSync; GenAI; COR-INSIGHT; COR INSIGHTS; INSIGHT REPORT; Respiratory ECG; SAMD; direct-from-ECG; ECG Derived Indications; Electrical Remodeling

Outcome Measures

Primary Outcomes (4)

• Screen Positive Accuracy for Cardiovascular Indication Panel Assessed Using CardioMIND

  The primary endpoint of this trial, for subjects participating in Subprotocols A through H, is to demonstrate screen-positive accuracy-sensitivity (True Positive Rate) exceeding 80%. This applies when a participant is indicated as having a cardiovascular condition based on COR ECG (COR 1.0 or COR 2.0) data analyzed using CardioMIND. Accuracy is assessed for substantial agreement on a per-indication basis, compared against results from an approved reference device or validated against electronic medical records (EMR) for previously diagnosed subjects.

  Through study completion - average of 18-months

• Screen Negative Accuracy for Cardiovascular Indication Panel Assessed Using CardioMIND

  The primary endpoint of this trial, for subjects participating in Subprotocols A through H, is to demonstrate screen-negative accuracy-specificity (True Negative Rate) exceeding 90%. This applies when a participant is indicated as negative or normal for a cardiovascular condition based on COR ECG (COR 1.0 or COR 2.0) data analyzed using CardioMIND. Screen-negative accuracy is assessed for substantial agreement on a per-indication basis, compared against results from an approved reference device or validated against electronic medical records (EMR) for subjects screened for the condition within 30 days of the study visit.

  Through study completion - average of 18-months

• Agreement of CO, SV and RSA Cardiopulmomary Panel Assessed Using Peerbridge CORMDX ECG Data with CardioQSync software

  The primary endpoint of this trial, for subjects participating in Subprotocols G and H, is to demonstrate statistical agreement with bias (mean difference ) of less than +/- 10% and standard difference to be within +/- 15% between non-invasive hemodynamic metrics (CO, SV and RSA) assessed using CardioQSync and cleared non-invasive hemodynamic Reference System using only 5 minutes of CORMDx (or COR 2.0) ECG wearable data. Accuracy is assessed for substantial agreement on a per-indication basis, compared against results from an approved reference device.

  Through study completion - average of 18-months

• Screen Positive and Screen Negative Accuracy for Obstructive Sleep Apnea (OSA) Metrics

  The primary endpoint for Sleep and OSA metrics (for Subprotocol B, C and D) is to demonstrate 1. screen positive accuracy - sensitivity (True Positive Rate) \> 90% where the participant has been indicated for OSA using COR ECG (COR 1.0 or COR 2.0) data with CardioMIND analysis. 2. Screen negative accuracy - specificity (True Negative Rate) \> 90% where the participated has been indicated negative or normal for OSA using COR ECG with CardioMIND analysis. 3. Statistical agreement between Apnea-Hypopnea Index (AHI) computed over one night of sleep between the output of COR ECG study data to the AHI output from an approved HST over one sleep night

  Through study completion - average of 18-months

Secondary Outcomes (3)

• Positive Predictive Value (PPV) for Indicated Cardiovascular Condition Using CardioMIND

  Through study completion - average of 18-months

• Negative Predictive Value (PPV) for Indicated Cardiovascular Condition Using CardioMIND

  Through study completion - average of 18-months

• Statistical Agreement Between The Proportion Of Screen Positive Cases With Clinically Significant CO & SV Changes That Require Interventions

  Through study completion - average of 18-months

Study Arms (1)

Cohort Breakdown to Power Accuracy Assessments

Up to a total of 15,000 subjects will be enrolled in the study covering all subprotocols (A through H). Data from a minimum of 500 subjects (covering all Subprotocols A through H) will be analyzed to evaluate primary and secondary endpoints. At least 3 subjects will be assigned to each Subprotocol (A through H) to characterize and demonstrate computability of each indication using CardioMIND and CardioQSync software. There are no upper limits on the number of subjects that can be assigned to any individual Subprotocol. The study shall have 1 study site with up to 50 sub-sites. All COR ECG studies started with PHS at subject's home will be assigned to a single sub-site.

Device: SUBPROTOCOL A; Device: SUBPROTOCOL B; Device: SUBPROTOCOL C; Device: SUBPROTOCOL D; Device: SUBPROTOCOL E; Device: SUBPROTOCOL F; Device: SUBPROTOCOL G; Device: SUBPROTOCOL H

Interventions

SUBPROTOCOL A DEVICE

A 30-minute COR ECG recording will be performed, including 15 minutes of continuous sitting data used for clinical indication analysis through CardioMIND software. Data collection can occur in-clinic, via PHS, or using a shipped device with telehealth support. Sleep, HRV, and AFIB risk analysis will not be included.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL B DEVICE

Subjects will undergo 24 hours of COR ECG recording, which must include at least one 15-minute unsupervised sitting session. Data analysis will include sleep patterns, HRV, and AFIB risk. ECG acquisition may take place in-clinic, via Patient Home Setup (PHS), or with a shipped device.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL C DEVICE

COR 1.0 ECG recordings will be conducted over 2 to 7 days, with at least one 15-minute unsupervised sitting session. At least 25% of randomly selected trial participants subjects will also wear a cleared wrist or finger device to track SpO2 during sleep. PI or Sub-Investigator will assign the number of wear days to the subject. The analysis will include sleep data, HRV, and AFIB risk assessment.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL D DEVICE

COR 2.0 (CORMDX) recordings will be conducted over 2 to 14 days, with at least one 15-minute unsupervised sitting session. At least 25% of randomly selected trial participants will also wear a cleared wrist or finger device to track SpO2 during sleep nights. PI or Sub-Investigator will assign the number of wear days to the subject. The analysis will include sleep data, HRV, and AFIB risk assessment.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL E DEVICE

Subjects will complete a 30-minute CORMDx (COR 2.0) ECG recording, with 15 minutes of continuous sitting data used for clinical indication analysis. Sleep, HRV, and AFIB risk analysis will not be performed.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL F DEVICE

A 30-minute COR 2.0 ECG recording will be completed, along with a 12-lead resting ECG using an FDA-cleared reference device. Sleep, HRV, and AFIB analysis will not be performed.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL G DEVICE

A 40-minute COR 2.0 recording will be conducted in two phases: 15 minutes of upright sitting and 15 minutes in a supine position. Hemodynamic monitoring, including blood pressure, cardiac output, and stroke volume variation, will be conducted using an FDA-cleared reference device. No sleep, HRV, or AFIB analysis will be performed.

Cohort Breakdown to Power Accuracy Assessments

SUBPROTOCOL H DEVICE

Subjects will undergo a 40-minute COR 2.0 recording, followed by a 40-minute COR 1.0 recording. Hemodynamic monitoring using an FDA-cleared reference device will be performed during both sessions. The transition between devices must occur within 60 minutes if the same adhesive is reused. Sleep, HRV, and AFIB analysis will not be performed.

Cohort Breakdown to Power Accuracy Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited from the community population receiving treatments or affiliated with participating subsites. These subsites will include hospitals, cardiac/medical/academic research centers, and medical practice clinics. It is anticipated that upto 50 trial sub-sites distributed across the United States will participate in the study. Enrollment will include healthy, diagnosed and undiagnosed community patients that could be at risk for cardiovascular, cardiopulmomary and sleep disorders. Participating subsite clinicans may enroll subjects with non-cardiac co-morbidities such as diabetes, neural and renal conditions to assess cardiac risk. The study population will comprise both male and female participants, as several indications being assessed have gender specific thresholds for calling presence of a medical condition.

You may qualify if:

• Age ≥ 18 years
• Able and eligible to wear a Holter monitor

You may not qualify if:

• Receiving any mechanical (respiratory or circulatory) or renal support therapy at Screening or during Visit #1.
• Any other conditions that in the opinion of the investigators are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study.
• Poor tolerance, susceptibility to severe skin reactions from ECG adhesive.

Sponsors & Collaborators

• Peerbridge Health, Inc: lead

Study Sites (1)

Peerbridge Health, Melbourne, Florida 32935

Melbourne, Florida, 32935, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure; Syncope; ST Elevation Myocardial Infarction; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Block; Cardiac Output, Low; Hyperkalemia; Hypercalcemia; Hypocalcemia; Ventricular Dysfunction, Left; Long QT Syndrome; Pericarditis; Sleep Apnea, Obstructive; Infarction; Cardiomyopathies; Hypertrophy; Atrial Remodeling

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cardiac Conduction System Disease; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Ventricular Dysfunction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathological Conditions, Anatomical

Study Officials

• Sandeep Gulati, PhD

  Peerbridge Health, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 8, 2025
• Study Start: November 16, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 60 days after Trial Scoring is Completed. Expected Around March 2026. Will be available for 3 years after the date.
• Access Criteria: Trial Site PI and study staff, All Site Sub-Investigators and their SubSite Research Staff, Trial SubSite Affiliates, Data Safety Monitoring Board (DSMB)Members, KOLs invited to Data Reviews and Affiliates; Publication submissions sites if required.

Locations

US (1)