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

Sponsor
Yonsei University
Study ID
NCT07622485
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.

Primary Outcome Measure

Composite incidence of major adverse cardiovascular events (MACE) [ Time Frame: Within 6 months after admission ]

Central Contacts

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