Not Yet RecruitingNot Applicable

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

South Korea1,500 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: * 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-admitte…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing wearable monitoring devices to standard hospital care for conditions like acute coronary syndrome and heart failure — given my specific diagnosis, does my doctor think continuous wearable monitoring during my hospital stay could realistically make a difference in catching problems earlier for someone in my situation?
2Since this trial hasn't started recruiting yet, how long might it be before I could actually participate, and is waiting for this study a realistic option given how urgent my treatment needs are right now?
3The trial is measuring major adverse cardiovascular events like heart attacks and dangerous arrhythmias as its main outcome — what does my doctor think the realistic risks are of being in the standard care group rather than the wearable monitoring group if I were to enroll?
4This study is listed as Phase NA, which typically means it's evaluating a device or monitoring approach rather than a drug — can my doctor explain what that means for how much is already known about the safety and usefulness of these wearables compared to what I'd receive with standard hospital monitoring?
5Are there already proven monitoring or treatment options I should be considering right now instead of waiting for this trial to open, or is this study something worth revisiting once recruitment begins?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite incidence of major adverse cardiovascular events (MACE)

Timeframe: Within 6 months after admission

Trial details

NCT IDNCT07622485

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Deok-Kyu Cho, MD.

82-31-5189-9681 CHODK123@yuhs.ac

View on ClinicalTrials.gov More Cardiovascular Diseases trials