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

Launched by PEERBRIDGE HEALTH, INC · Jan 1, 2025

Keywords

ClinConnect Summary

The COR-INSIGHT trial tests whether two wearable ECG devices (COR 1.0 and the newer COR 2.0) equipped with AI software can accurately detect a wide range of heart and lung problems without invasive tests. Researchers want to see if these wearables can correctly identify conditions like heart failure, heart attacks, rhythm problems, sleep apnea, and related issues, by comparing their results with standard, proven tests. The study includes eight smaller sub-studies and aims to show high accuracy (sensitive enough to catch problems and specific enough to avoid false alarms) and good agreement with other medical tests. Up to 15,000 people across many U.S. sites will be enrolled.

Who can join and what to expect: Adults aged 18 or older who can wear a Holter-style monitor are eligible, including people with known or suspected heart or lung problems as well as some healthy volunteers. People needing certain life-support therapies or with conditions that could unsafe participation are excluded. Participants will wear the COR devices for as little as 30 minutes or up to 14 days, depending on the sub-study, in settings such as home, clinic, or hospital. Some sub-studies also collect sleep data or other heart-lunc measurements. You’ll consent to participate, and your device data will be compared with standard tests to judge accuracy. The main risks are small skin irritation from the adhesives, and the study will share de-identified data with researchers after completion to advance learning.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Able and eligible to wear a Holter monitor
• Exclusion Criteria:
• • 1. Receiving any mechanical (respiratory or circulatory) or renal support therapy at Screening or during Visit #1.
• • 2. 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.
• • 3. Poor tolerance, susceptibility to severe skin reactions from ECG adhesive.