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

NCT07622485 | Not Yet Recruiting DMC

• 1 other identifier: INSPIRE trial
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Heart Failure; Cardiac Arrhythmia; Peripheral Arterial Disease

Keywords

wearable device; continuous monitoring; remote monitoring; stepped-wedge cluster trial; major adverse cardiovascular events; digital health; inpatient monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• In-hospital cardiac arrest

  Through hospital discharge, up to 30 days

• ICU transfer rate

  Through hospital discharge, up to 30 days

• Length of hospital stay

  Through hospital discharge, up to 30 days

• Accuracy of wearable vital-sign measurement

  Through hospital discharge, up to 30 days

• Arrhythmia detection performance

  Through hospital discharge, up to 30 days

Study Arms (2)

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.

Device: thynC Inpatient Monitoring System

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.

Interventions

thynC Inpatient Monitoring System DEVICE

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.

Wearable-based monitoring (intervention)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Heart Failure; Arrhythmias, Cardiac; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Deok-Kyu Cho, MD.

  Yongin Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Deok-Kyu Cho, MD.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

KR (1)