Cardiovascular DiseasesNCT07622485
In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)
A study testing thynC Inpatient Monitoring System in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure
- What is being tested?
- thynC Inpatient Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei University Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995
Deok-Kyu Cho, MD., 82-31-5189-9681, CHODK123@yuhs.ac
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Cardiac Arrhythmia, Peripheral Arterial Disease
- Being tested
- thynC Inpatient Monitoring System
- Keywords
- wearable device, continuous monitoring, remote monitoring, stepped-wedge cluster trial, major adverse cardiovascular events, digital health, inpatient monitoring
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Arrhythmias, Cardiac, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thynC Inpatient Monitoring SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months after admission
Secondary outcomes (12)
In-hospital cardiac arrest
Incidence of cardiac arrest during hospitalization.
Measured: Through hospital discharge, up to 30 days
ICU transfer rate
Proportion of patients transferred to the intensive care unit during hospitalization.
Measured: Through hospital discharge, up to 30 days
Length of hospital stay
Number of days from admission to discharge
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 6 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deok-Kyu Cho, Yonsei University
- Investigators
- Deok-Kyu Cho, MD., Principal investigator, Yongin Severance Hospital, Yonsei University College of MedicineSungA Bae, MD., PhD., Study director, Yongin Severance Hospital, Yonsei University College of MedicineOh-Hyun Lee, MD., PhD., Study director, Yongin Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622485
- Sponsor's protocol ID
- INSPIRE trial
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)
- ClinicalTrials.gov ID
- NCT07622485
- Acronym / sponsor ID
- INSPIRE trial
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Wearable-based monitoring (intervention) | Experimental | Device: thynC Inpatient Monitoring SystemDuring 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thynC Inpatient Monitoring SystemA 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. | Device | Wearable-based monitoring (intervention) |
Primary outcome
Composite incidence of major adverse cardiovascular events (MACE)
Time frame: 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.
12 secondary outcomes
In-hospital cardiac arrest
Time frame: Through hospital discharge, up to 30 days
ICU transfer rate
Time frame: Through hospital discharge, up to 30 days
Length of hospital stay
Time frame: Through hospital discharge, up to 30 days
Accuracy of wearable vital-sign measurement
Time frame: Through hospital discharge, up to 30 days
Arrhythmia detection performance
Time frame: Through hospital discharge, up to 30 days
Early detection rate of vital-sign abnormality
Time frame: Through hospital discharge, up to 30 days
Device-related adverse events
Time frame: Through hospital discharge, up to 30 days
Cardiovascular death
Time frame: Within 6 months after admission
Non-fatal myocardial infarction
Time frame: Within 6 months after admission
Non-fatal stroke
Time frame: Within 6 months after admission
Unplanned revascularization
Time frame: Within 6 months after admission
Cardiovascular rehospitalization
Time frame: Within 6 months after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deok-Kyu Cho, MD. principal investigator
Yongin Severance Hospital, Yonsei University College of Medicine
SungA Bae, MD., PhD. study director
Yongin Severance Hospital, Yonsei University College of Medicine
Oh-Hyun Lee, MD., PhD. study director
Yongin Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thynC Inpatient Monitoring System in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deok-Kyu Cho, MD. (82-31-5189-9681, CHODK123@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of major adverse cardiovascular events (MACE) (time frame: Within 6 months after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.