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

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Deok-Kyu Cho, MD.
  • Telefonnummer: 82-31-5189-9681
  • E-mail: CHODK123@yuhs.ac

Studiesteder

  • Sydkorea
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, Sydkorea, 16995
        • Yonsei University Yongin Severance Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite incidence of major adverse cardiovascular events (MACE)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
In-hospital cardiac arrest
Tidsramme: Through hospital discharge, up to 30 days
Incidence of cardiac arrest during hospitalization.
Through hospital discharge, up to 30 days
ICU transfer rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yonsei University

Efterforskere

  • Ledende efterforsker: Deok-Kyu Cho, MD., Yongin Severance Hospital, Yonsei University College of Medicine
  • Studieleder: SungA Bae, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine
  • Studieleder: Oh-Hyun Lee, MD., PhD., Yongin Severance Hospital, Yonsei University College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INSPIRE trial

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