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

1 giugno 2026 aggiornato da: Deok-Kyu Cho, Yonsei University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Deok-Kyu Cho, MD.
  • Numero di telefono: 82-31-5189-9681
  • Email: CHODK123@yuhs.ac

Luoghi di studio

  • Corea del Sud
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, Corea del Sud, 16995
        • Yonsei University Yongin Severance Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Composite incidence of major adverse cardiovascular events (MACE)
Lasso di tempo: 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.
Within 6 months after admission

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
In-hospital cardiac arrest
Lasso di tempo: Through hospital discharge, up to 30 days
Incidence of cardiac arrest during hospitalization.
Through hospital discharge, up to 30 days
ICU transfer rate
Lasso di tempo: Through hospital discharge, up to 30 days
Proportion of patients transferred to the intensive care unit during hospitalization.
Through hospital discharge, up to 30 days
Length of hospital stay
Lasso di tempo: Through hospital discharge, up to 30 days
Number of days from admission to discharge
Through hospital discharge, up to 30 days
Accuracy of wearable vital-sign measurement
Lasso di tempo: Through hospital discharge, up to 30 days
Agreement (intraclass correlation coefficient) between wearable-device measurements and reference nursing measurements.
Through hospital discharge, up to 30 days
Arrhythmia detection performance
Lasso di tempo: 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.
Through hospital discharge, up to 30 days
Early detection rate of vital-sign abnormality
Lasso di tempo: Through hospital discharge, up to 30 days
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
Lasso di tempo: Through hospital discharge, up to 30 days
Incidence of adverse events related to the wearable device (skin irritation, allergic reaction, discomfort).
Through hospital discharge, up to 30 days
Cardiovascular death
Lasso di tempo: 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.
Within 6 months after admission
Non-fatal myocardial infarction
Lasso di tempo: 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.
Within 6 months after admission
Non-fatal stroke
Lasso di tempo: 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.
Within 6 months after admission
Unplanned revascularization
Lasso di tempo: 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.
Within 6 months after admission
Cardiovascular rehospitalization
Lasso di tempo: 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.
Within 6 months after admission

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Yonsei University

Investigatori

  • Investigatore principale: Deok-Kyu Cho, MD., Yongin Severance Hospital, Yonsei University College of Medicine
  • Direttore dello studio: SungA Bae, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine
  • Direttore dello studio: Oh-Hyun Lee, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INSPIRE trial

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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