In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)

Starting soon · Not applicable

Conditions studied: Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Cardiac Arrhythmia, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT07622485

Run by

Yonsei University

People needed

1500

Starts

2026-07-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-03

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use
• Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)
• Unable to communicate in Korean for study explanation and the consent process
• Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)
• Considered inappropriate for participation by the investigator

Where it is running

• Yonsei University Yongin Severance Hospital — Yongin, Gyeonggi-do, South Korea

Full record on ClinicalTrials.gov

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