myocardial infarction, STEMI heart attack
Conditions
Interventions
Participating patients will receive standard post-PCI cardiac care supplemented with continuous physiological monitoring.  
Continuous physiological monitoring is solely used for study data and does not require nursing capacity. This device will be applied in addition to the hospital’s regular telemetry system, which will
Following initial stabilization on the CCU eligible low-risk STEMI patients will be relocated within 12 hours after PCI to a dedicated “living room” area on the cardiology ward. This environment simul
During the study period, clinical interactions with healthcare providers (cardiologists and nursing staff) will take place digitally or by telephone, reflecting the envisioned remote-care model. In ca
 
Family members are allowed to be present in the room and stay overnight. They will assist w
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Age = 18 years.Diagnosis of STEMISuccessful and uncomplicated primary PCIZwolle risk score = 3Considered clinically stable for relocation to the cardiology ward within 12 hours after PCI by the supervising cardiologistWillingness to participate, including the ability to provide written informed consentPresence of at least one caregiver/family member who is willing and able to participate in the study procedures.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Complicated or unstable clinical course after PCI (e.g., hemodynamic instability or ongoing ischemia)Contraindications for early relocation as assessed by the treating cardiologistInability to use or tolerate the wearable monitoring systemCognitive impairment or language barrier that precludes understanding of the study procedures or informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter is the feasibility of very early relocation (<12 hours post-PCI) of low-risk STEMI patients after primary PCI, supported by continuous physiological monitoring and digital consultation with doctors and nurses of the cardiology department within a home-like environment. Feasibility will be primarily assessed using the Post-Study System Usability Questionnaire (PSSUQ), a validated instrument that measures user satisfaction and perceived usability of systems [12]. The total and subscale scores will provide a quantitative evaluation of feasibility and user experience with the monitoring setup. In addition, supportive descriptive feasibility indicators will be collected to complement the PSSUQ results. These indicators include:Completion of the 48-hour observation period without premature termination for clinical or organizational reasons.Completion of self-measurements of vital parameters (blood pressure, pulse pressure, oxygen saturation, temperature)Successfully maintained duration of continuous physiological monitoring compared to the intended duration.Successful completion of planned digital consultations and family-assisted measurements. Feasibility will be evaluated at the end of the 48-hour observation period. Descriptive summaries will be provided for the overall proportion of patients meeting predefined criteria, as well as narrative descriptions of any deviations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will focus on the experiences of patients and family members, as well as the room visits of nursing staff. Patient-related endpoints (questionnaires and interview)For patients, secondary outcomes include perceived safety, comfort, and willingness for future use of remote monitoring, assessed through a brief set of Likert-scale items complementing the PSSUQ. In addition, semi-structured interviews will explore patients’ overall experiences with early relocation, digital consultations, and continuous monitoring in the simulated home environment. Family member-related endpoints (questionnaires and interview)For family members, secondary endpoints focus on the feasibility and perceived burden of assisting with basic measurements, as well as their sense of safety and involvement in the care process. Quantitative assessment will include the validated Zarit Burden Interview-12 (ZBI-12), supplemented by short Liker-scale questions on feasibility and safety [13]. Qualitative insights will be obtained through a joint semi-structured interview with the patient. Nursing-related endpoints (documentation)For nursing staff, secondary outcomes will include the frequency and reasons for in-room visits, such as responses to telemetry alarms, technical issues, or patient requests. These data will be collected through structured documentation, providing descriptive insight into workflow and workload. | — |
Countries
Netherlands
Contacts
Public ContactR Dijkman
Radboud Universitair Medisch Centrum
Outcome results
None listed