COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications from the COR ECG Wearable
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Screen Positive Accuracy for Cardiovascular Indication Panel Assessed Using CardioMIND
研究概览
简要总结
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.
详细描述
The COR-INSIGHT trial is a clinical study designed to evaluate the effectiveness of Peerbridge COR ambulatory ECG wearables, COR 1.0 and COR 2.0 ("CORMDX"). These devices integrate advanced AI technologies, including CardioMIND and CardioQSync, to accurately detect a broad spectrum of cardiovascular and cardiopulmonary conditions. By offering multiplexed diagnostics via direct-from-ECG analysis, the trial seeks to validate an alternative to traditional diagnostic modalities such as imaging, catheter-based techniques, and biochemical assays.
COR-INSIGHT study is validating a comprehensive, non-invasive screening framework designed to benefit cardiac patients, including those who are asymptomatic, critically ill, or awaiting procedures such as ablation, transcatheter aortic valve replacement (TAVR), transcatheter aortic valve implantation (TAVI), or implantable cardioverter defibrillator (ICD) placement. Additionally, the protocol addresses the needs of patients with cardiopulmonary conditions, offering precise diagnostics and remote monitoring capabilities in hospital, outpatient, and home-based environments.
Objectives
The COR-INSIGHT trial is structured around clearly defined objectives aimed at demonstrating the clinical efficacy and utility of COR wearable ECG:
- Primary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Able and eligible to wear a Holter monitor
排除标准
- •Receiving any mechanical (respiratory or circulatory) or renal support therapy at Screening or during Visit #
- •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.
- •Poor tolerance, susceptibility to severe skin reactions from ECG adhesive.
结局指标
主要结局
Screen Positive Accuracy for Cardiovascular Indication Panel Assessed Using CardioMIND
时间窗: Through 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 CardioMIND
时间窗: Through 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 software
时间窗: Through 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) Metrics
时间窗: Through 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
次要结局
- Positive Predictive Value (PPV) for Indicated Cardiovascular Condition Using CardioMIND(Through study completion - average of 18-months)
- Negative Predictive Value (PPV) for Indicated Cardiovascular Condition Using CardioMIND(Through study completion - average of 18-months)
- Statistical Agreement Between The Proportion Of Screen Positive Cases With Clinically Significant CO & SV Changes That Require Interventions(Through study completion - average of 18-months)