NCT07622485Not yet recruiting
In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)
In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 27 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Yonsei University
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07622485
What you commit to
- Study type: Interventional
- Planned participants: 1500
- From 1 Jul 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Yongin Severance Hospital Coordinator of this site? Confirm its status | Yongin | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.