Acute Coronary Syndrome, Cardiac Arrhythmia, Cardiovascular Diseases, Heart Failure, Peripheral Arterial Disease
Conditions
Keywords
wearable device, continuous monitoring, remote monitoring, stepped-wedge cluster trial, major adverse cardiovascular events, digital health, inpatient monitoring
Brief 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.
Detailed description
Study design: This is a prospective, stepped-wedge cluster-randomized, open-label trial with blinded endpoint adjudication, designed to test the superiority of wearable-based monitoring over standard care. Unit of randomization: The unit of randomization is the inpatient ward zone (cluster), not the individual patient. Four clusters (ward zones 121A, 121B, 122A, and 122B at Yongin Severance Hospital) participate. The trial comprises five periods (one baseline period plus four step periods), each lasting five months. In period 1 all four clusters operate under standard care; thereafter, one cluster per period transitions to the wearable-monitoring intervention in a computer-generated random order, until all clusters are in the intervention state in period 5. Once a cluster transitions to the intervention state it remains so until the end of the trial. Intervention: Patients admitted to a cluster operating in the intervention state receive continuous wearable monitoring (thynC Inpatient Monitoring System: continuous ECG, heart rate, respiratory rate, oxygen saturation, and body temperature with a real-time central alerting system) in addition to standard care. Patients admitted to a cluster operating in the control state receive standard care (intermittent nursing vital-sign measurement every 4 to 8 hours). Outcome and follow-up: The primary outcome is the composite incidence of MACE within 6 months. Each participant is followed for 6 months from admission. Total study duration is approximately 36 months (25 months of enrollment, 6 months of follow-up after the last enrolled patient, and 5 months of analysis). Patients and care providers are not masked to allocation; the primary and major secondary endpoints are adjudicated by an independent committee blinded to cluster allocation and study period.
Interventions
DEVICEthynC 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/Yellow) alerts. Worn from admission until discharge.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Open-label for participants and care providers. The primary and major secondary endpoints are adjudicated by an independent endpoint adjudication committee blinded to cluster allocation and study period.
Intervention model description
Stepped-wedge cluster-randomized design. The unit of randomization is the inpatient ward zone (cluster). Four clusters cross over from standard care to the wearable-monitoring intervention in a randomized sequence over five 5-month periods (one baseline period plus four step periods).
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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-admitted patients are not re-enrolled; each participant is enrolled only at the first admission) * Considered inappropriate for participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite incidence of major adverse cardiovascular events (MACE) | Within 6 months after admission | Composite of cardiovascular death, myocardial infarction, stroke, unplanned revascularization (PCI or CABG), and cardiovascular rehospitalization, adjudicated by a blinded endpoint adjudication committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital cardiac arrest | Through hospital discharge, up to 30 days | Incidence of cardiac arrest during hospitalization. |
| ICU transfer rate | Through hospital discharge, up to 30 days | Proportion of patients transferred to the intensive care unit during hospitalization. |
| Length of hospital stay | Through hospital discharge, up to 30 days | Number of days from admission to discharge |
| Accuracy of wearable vital-sign measurement | Through hospital discharge, up to 30 days | Agreement (intraclass correlation coefficient) between wearable-device measurements and reference nursing measurements. |
| Arrhythmia detection performance | Through hospital discharge, up to 30 days | Sensitivity, specificity, and positive and negative predictive values of wearable arrhythmia detection compared with standard ECG/Holter monitoring. |
| Early detection rate of vital-sign abnormality | Through hospital discharge, up to 30 days | Proportion of vital-sign abnormalities with a clinical response within 30 minutes of the abnormality. |
| Device-related adverse events | Through hospital discharge, up to 30 days | Incidence of adverse events related to the wearable device (skin irritation, allergic reaction, discomfort). |
| Cardiovascular death | Within 6 months after admission | Death attributable to cardiovascular causes, including fatal myocardial infarction, fatal stroke, sudden cardiac death, heart failure death, and death due to other cardiovascular causes, adjudicated by a blinded endpoint adjudication committee. |
| Non-fatal myocardial infarction | Within 6 months after admission | Non-fatal myocardial infarction defined according to the Fourth Universal Definition of Myocardial Infarction, adjudicated by a blinded endpoint adjudication committee. |
| Non-fatal stroke | Within 6 months after admission | Non-fatal ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI) with corresponding neurologic deficit lasting more than 24 hours, adjudicated by a blinded endpoint adjudication committee. |
| Unplanned revascularization | Within 6 months after admission | Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) performed for clinical indications and not planned at the time of the index hospitalization, adjudicated by a blinded endpoint adjudication committee. |
| Cardiovascular rehospitalization | Within 6 months after admission | Unscheduled rehospitalization due to a cardiovascular cause, including heart failure, acute coronary syndrome, arrhythmia, or other cardiovascular conditions, occurring after discharge from the index hospitalization, adjudicated by a blinded endpoint adjudication committee. |
Countries
South Korea
Contacts
CONTACTDeok-Kyu Cho, MD.
PRINCIPAL_INVESTIGATORDeok-Kyu Cho, MD.
Yongin Severance Hospital, Yonsei University College of Medicine
STUDY_DIRECTORSungA Bae, MD., PhD.
Yongin Severance Hospital, Yonsei University College of Medicine
STUDY_DIRECTOROh-Hyun Lee, MD., PhD.
Yongin Severance Hospital, Yonsei University College of Medicine
Outcome results
None listed