[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640379":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":40,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":18,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":74,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Wearable-based monitoring (intervention)","EXPERIMENTAL","During periods in which the patient's cluster operates in the intervention state, patients receive continuous wearable monitoring using the thynC Inpatient Monitoring System with a real-time alerting system, in addition to standard care.",[13],"Device: thynC Inpatient Monitoring System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care (control)","NO_INTERVENTION","During periods in which the patient's cluster operates in the control state, patients receive standard care, including intermittent nursing vital-sign measurement every 4 to 8 hours.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","thynC Inpatient Monitoring System","A 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\u002FYellow) alerts. Worn from admission until discharge.",[9],[26,30,33],{"name":27,"affiliation":28,"role":29},"Deok-Kyu Cho, MD.","Yongin Severance Hospital, Yonsei University College of Medicine","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":32},"SungA Bae, MD., PhD.","STUDY_DIRECTOR",{"name":34,"affiliation":28,"role":32},"Oh-Hyun Lee, MD., PhD.",[36],{"name":27,"role":37,"phone":38,"phoneExt":18,"email":39},"CONTACT","82-31-5189-9681","CHODK123@yuhs.ac",[41],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":18,"cosmosGeoPoint":18,"geoPoint":18,"contacts":47},"Yonsei University Yongin Severance Hospital","Yongin","Gyeonggi-do","16995","South Korea",[48],{"name":27,"role":37,"phone":38,"phoneExt":18,"email":39},{"type":29,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Deok-Kyu Cho","Professor","100640379","in-hospital-wearable-based-monitoring-versus-standard-care-in-cardiovascular-disease-inspire-100640379",false,"NCT07622485","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)","Inclusion Criteria:\n\nAdults aged 20 years or older\n\n* 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\n* Able to provide written informed consent\n* Able to wear the wearable monitoring device\n\nExclusion Criteria:\n\n* Hemodynamically unstable shock (sustained systolic blood pressure \\\u003C 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)\n* Planned or current intensive care unit admission\n* Within 24 hours after cardiopulmonary resuscitation\n* 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)\n* Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use\n* Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)\n* Unable to communicate in Korean for study explanation and the consent process\n* Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)\n* Considered inappropriate for participation by the investigator","ALL","20 Years",{"count":62,"type":63},1500,"ESTIMATED","INTERVENTIONAL",[66],"NA","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.",[69,70,71,72,73],"Cardiovascular Diseases","Acute Coronary Syndrome","Heart Failure","Cardiac Arrhythmia","Peripheral Arterial Disease",[75,76,77,78,79,80,81],"wearable device","continuous monitoring","remote monitoring","stepped-wedge cluster trial","major adverse cardiovascular events","digital health","inpatient monitoring","NOT_YET_RECRUITING","2026-06-01",{"date":85,"type":86},"2026-06-03","ACTUAL",{"date":88,"type":63},"2026-07-01",{"date":90,"type":63},"2029-12-31",{"name":5,"class":6},1]