Wearable monitoring compared with usual checks for hospitalized heart and blood vessel patients
Tests a wireless wearable monitor against usual checks in hospitalized adults with heart disease.
Plain-language title generated from the registry record
Registry title: In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)
Key facts
- Where
- Yongin, South KoreaSee the site
Where in South Korea
- Yonsei University Yongin Severance HospitalYongin, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yonsei University
- Trial code
- NCT07622485
- Record updated
- 3 June 2026
- Original description
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.Read full original descriptionShow less
In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)
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.
Inclusion: Adults aged 20 years or older; 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.
Exclusion: Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible); Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission); 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); Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use; 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; Unable to communicate in Korean for study explanation and the consent process; Considered inappropriate for participation by the investigator.