Patients hospitalized with cardiovascular disease require timely detection of clinical deterioration to prevent adverse outcomes. Standard inpatient care relies on intermittent nursing vital-sign measurements performed every 4 to 8 hours, which can miss hemodynamic or arrhythmic events occurring between measurements. This trial evaluates whether digital wearable-based monitoring - wireless continuous measurement of vital signs and electrocardiography with a real-time alerting system - reduces major adverse cardiovascular events (MACE) compared with standard intermittent monitoring in patients hospitalized for cardiovascular disease. The trial uses a stepped-wedge cluster-randomized design in which four inpatient ward zones (clusters) are sequentially transitioned from standard care to wearable monitoring over five periods.
Hospitalized for cardiovascular disease, with at least one of: acute coronary syndrome; chronic coronary syndrome; acute heart failure (NYHA class III-IV or acute decompensated heart failure); arrhythmia (atrial fibrillation, ventricular tachycardia, complete AV block, or other clinically significant arrhythmia); peripheral arterial or aortic disease; post-cardiovascular-procedure observation (PCI, CABG, valve surgery, or electrophysiology study); or thromboembolic disease
Able to provide written informed consent
Able to wear the wearable monitoring device
Hemodynamically unstable shock (sustained systolic blood pressure < 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)
Planned or current intensive care unit admission
Within 24 hours after cardiopulmonary resuscitation
Physical condition precluding device wearing (bilateral upper-limb amputation; severe skin lesion, burn, or open wound at the device site; known allergy to device materials)
Parallel
thynC Inpatient Monitoring System
DeviceA wearable continuous monitoring system comprising an ECG patch, a temperature patch, and a pulse oximeter that wirelessly transmit continuous vital-sign and electrocardiographic data to a central monitoring system with automated two-tier (Red/Yellow) alerts. Worn from admission until discharge.
Composite incidence of major adverse cardiovascular events (MACE)
Composite of cardiovascular death, myocardial infarction, stroke, unplanned revascularization (PCI or CABG), and cardiovascular rehospitalization, adjudicated by a blinded endpoint adjudication committee.
In-hospital cardiac arrest
Incidence of cardiac arrest during hospitalization.
ICU transfer rate
Proportion of patients transferred to the intensive care unit during hospitalization.
Length of hospital stay
Number of days from admission to discharge
Accuracy of wearable vital-sign measurement
Agreement (intraclass correlation coefficient) between wearable-device measurements and reference nursing measurements.
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