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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Heart Failure; Peripheral Arterial Disease; Acute Coronary Syndrome; Cardiac Arrhythmia
• Intervention / Treatment: Device: thynC Inpatient Monitoring System

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deok-Kyu Cho, MD.; Phone Number: 82-31-5189-9681; Email: CHODK123@yuhs.ac

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yonsei University Yongin Severance Hospital
      • Contact: Deok-Kyu Cho, MD.; Phone Number: 82-31-5189-9681; Email: CHODK123@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable-based monitoring (intervention); 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.	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/Yellow) alerts. Worn from admission until discharge.
No Intervention: Standard care (control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite incidence of major adverse cardiovascular events (MACE)	Composite of cardiovascular death, myocardial infarction, stroke, unplanned revascularization (PCI or CABG), and cardiovascular rehospitalization, adjudicated by a blinded endpoint adjudication committee.	Within 6 months after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital cardiac arrest	Incidence of cardiac arrest during hospitalization.	Through hospital discharge, up to 30 days
ICU transfer rate	Proportion of patients transferred to the intensive care unit during hospitalization.	Through hospital discharge, up to 30 days
Length of hospital stay	Number of days from admission to discharge	Through hospital discharge, up to 30 days
Accuracy of wearable vital-sign measurement	Agreement (intraclass correlation coefficient) between wearable-device measurements and reference nursing measurements.	Through hospital discharge, up to 30 days
Arrhythmia detection performance	Sensitivity, specificity, and positive and negative predictive values of wearable arrhythmia detection compared with standard ECG/Holter monitoring.	Through hospital discharge, up to 30 days
Early detection rate of vital-sign abnormality	Proportion of vital-sign abnormalities with a clinical response within 30 minutes of the abnormality.	Through hospital discharge, up to 30 days
Device-related adverse events	Incidence of adverse events related to the wearable device (skin irritation, allergic reaction, discomfort).	Through hospital discharge, up to 30 days
Cardiovascular death	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.	Within 6 months after admission
Non-fatal myocardial infarction	Non-fatal myocardial infarction defined according to the Fourth Universal Definition of Myocardial Infarction, adjudicated by a blinded endpoint adjudication committee.	Within 6 months after admission
Non-fatal stroke	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.	Within 6 months after admission
Unplanned revascularization	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.	Within 6 months after admission
Cardiovascular rehospitalization	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.	Within 6 months after admission

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Deok-Kyu Cho, MD., Yongin Severance Hospital, Yonsei University College of Medicine; Study Director: SungA Bae, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine; Study Director: Oh-Hyun Lee, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: digital health; wearable device; remote monitoring; major adverse cardiovascular events; continuous monitoring; inpatient monitoring; stepped-wedge cluster trial
• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Heart Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Heart Failure; Cardiovascular Diseases; Peripheral Arterial Disease; Acute Coronary Syndrome; Arrhythmias, Cardiac
• Other Study ID Numbers: INSPIRE trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No