COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sandeep Gulati, PhD · PRINCIPAL_INVESTIGATOR · Peerbridge Health, Inc
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
What this trial measures
- Screen Positive Accuracy for Cardiovascular Indication Panel Assessed Using CardioMINDThrough study completion - average of 18-months
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.
- Screen Negative Accuracy for Cardiovascular Indication Panel Assessed Using CardioMINDThrough study completion - average of 18-months
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.
- Agreement of CO, SV and RSA Cardiopulmomary Panel Assessed Using Peerbridge CORMDX ECG Data with CardioQSync softwareThrough study completion - average of 18-months
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.
- Screen Positive and Screen Negative Accuracy for Obstructive Sleep Apnea (OSA) MetricsThrough study completion - average of 18-months
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