COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
At a glance
Conditions
NCT06763549
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Peerbridge Health, Melbourne, Florida 32935
Melbourne, Floridano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study 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