The image showcases the Cor MDx, a sleek, compact wearable device designed for cardiac monitoring, prominently displayed at the HIMSS Global Health Co

The COR-INSIGHT Clinical Trial

Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications from the Cor® ECG Wearable

The COR-INSIGHT Clinical Trial

Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Indications from the Cor® ECG Wearable
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The COR-INSIGHT Clinical Trial

Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Indications from the Cor® ECG Wearable
This trial is an ongoing study to evaluate the effectiveness of the Peerbridge COR®, a one of a kind wearable heart monitor. In this trial, we are observing how well the COR® devices can accurately detect heart and lung conditions. These wearables use a unique AI-based software, called CardioMIND and CardioQSync, to analyze the heart's electrical signals. The goal of this trial is to see if these non-invasive devices are a reliable and easy way to spot serious health issues, all without needing any complicated, cumbersome, or uncomfortable procedures.
The COR-INSIGHT trial is exploring a new way to check for heart conditions that's completely different from traditional methods. Our devices use AI-powered technology to read your heart's electrical signals. These devices can be worn anywhere—at the hospital, a clinic, or even at home.The study will analyze this continuous heart data to see how accurately our devices can identify people with a condition versus those who are healthy. Our goal is to prove that this simple, wearable technology can be a reliable alternative to traditional, more invasive diagnostic tools.

Primary Objectives

2

Detect Indications 

To achieve sensitivity (>80%) and specificity (>90%) in detecting each cardiovascular and cardiopulmonary indication assessed in the study.

3

Validate PPV/NVP

To validate the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of AI-enabled diagnostics on per indication basis.

4

Measure Performance

To establish statistical concordance between COR ECG wearable outputs and standard reference devices, ensuring robust diagnostic performance for each indication assessed.

Secondary Objectives

1

Evaluate Monitoring Impact 

To evaluate the outcome and impact of continuous, non-invasive monitoring on early detection and personalized management.

6

Feasibility Study

To assess the scalability and feasibility of deploying COR devices in diverse healthcare settings, including underserved populations.

2-14 days
Trial period
15k
Participants enrolling
18+
Minimum age requirement
Cor Device

Eligibility Criteria

Participants must meet the following requirements:

  • 18 years of age or older
  • Eligible to wear a Holter

Final eligibility will be determined by the enrolling provider.

Participant Enrollment

The study will enroll up to 15,000 participants across diverse demographic and clinical backgrounds. Inclusion criteria prioritize patients with potential cardiovascular or cardiopulmonary conditions. Key aspects of participant management include:

  1. Screening and Consent: Comprehensive screening protocols to ensure eligibility and informed consent adherence.
  2. Blinded Data Handling: Participant history and demographics remain blinded during analysis to minimize bias.

  3. Protocol Compliance: Non-compliance or dropout cases are systematically excluded to maintain data integrity.

Safety and Ethical Considerations

The trial adheres to stringent ethical and safety standards:

  1. Risk Mitigation: Risks are limited to minor skin irritation from adhesive electrodes, with proactive monitoring to address adverse events.
  2. Ethical Compliance: Conducted under Good Clinical Practice (GCP) guidelines and robust data confidentiality protocols.
  3. Potential Benefits: Enhanced diagnostic accuracy, reduced reliance on invasive procedures, and improved accessibility to advanced healthcare.

Study Procedure

  1. Participants will be screened and enrolled by a healthcare provider.
  2. A COR wearable ECG patch will be applied In the physician’s office
  3. Participants will wear the device during normal daily activities for the duration of the monitoring period.
  4. After completion, the patient will return the sensor to Peerbridge Health for analysis. Results will be available in the Peerbridge Health Cor Portal.

Note: No additional clinic visits are required beyond standard care.

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Request Study Information

For additional information about the COR-INSIGHT study, or to determine whether a patient may be eligible for enrollment, please complete the contact form.

This research is conducted under IRB oversight. The device used in this study is investigational and not approved for commercial use. Participation is voluntary and will not impact the standard of care provided by your physician. Cor 2.0 (CorMDx) and the Insight Report are not available for sale in the United States and are under currently under clinical investigation.


IRB Approved October 11, 2024