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

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

Interventions

DEVICE

SUBPROTOCOL A

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.

DEVICE

SUBPROTOCOL B

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.

DEVICE

SUBPROTOCOL C

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.

DEVICE

SUBPROTOCOL D

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.

DEVICE

SUBPROTOCOL E

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.

DEVICE

SUBPROTOCOL F

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.

DEVICE

SUBPROTOCOL G

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.

DEVICE

SUBPROTOCOL H

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.

Sponsors & Collaborators

• Peerbridge Health, Inc

  lead INDUSTRY

Principal Investigators

• Sandeep Gulati, PhD · Peerbridge Health, Inc

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-16

Primary Completion

2026-04-15

Completion

2026-04-15

FDA Device

Yes

Countries

• United States

Study Locations