An interventional study of AI-assisted Clinical Assistant PMcardio in Cardiovascular Diseases, Medical Device and Primary Health Care, sponsored by Powerful Medical. Completed at 56 sites in Slovakia. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Powerful Medical · Not applicable, Interventional, and Treatment
This study aimed to analyze and investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to evaluate time savings and cost saving implications of increased availability of specialised care at the primary care level.
It is a multi-centric, physician-driven, patient-blinded randomized controlled trial of patients presenting to the general practitioner with typical cardiovascular symptoms (specifically, chest pain, syncope, palpitations, or shortness of breath) constituting an electrocardiogram examination. Eligible patients will be enrolled at the participating general practitioner clinics and managed either through the PMcardio platform with AI-assisted diagnostics, patient management recommendations or usual standard of care throughout their initial visit. Enrolled participants will be followed-up through health insurance billing codes and there will be no personal follow-up visits required. The aim of the study is to investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to assess time savings and cost saving implications of increased availability of specialised care at the primary care level.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's enrollment of 836 is above the median of 48 across 430 interventional studies indexed under Dyspnea.
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Exclusion Criteria:
AI-assisted interpretation of the ECG including the predicted ECG diagnoses, disease-specific anamnestic questions, and patient management recommendations for referral to secondary care, including suggestions for procedures and further diagnostic tests
Device: AI-assisted Clinical Assistant PMcardio
The usual standard of care, with NO AI-based diagnosis or treatment recommendation available.
PMcardio is an AI-powered clinical assistant in the form of a mobile application empowering non-cardiologist healthcare workers with advanced cardiovascular diagnostic capabilities, recommending patient-specific suggestions for referral and facilitating remote consultations with specialized cardiologists.
Time to first cardiovascular-related consultation
Time from randomization to the first cardiovascular-related consultation or a follow-up visit at specialized physician in patients, where specialized consultation is indicated based on the general practitioner recommendation after using PMcardio application. The measurement will be assessed from the data received from the health insurance provider.
Time frame: From randomization to enrollment period completion (up to 6 months)
Time to first cardiovascular-related diagnostic testing
Time from randomization to the first cardiovascular-related further diagnostic testing (laboratory parameters, ECG Holter, echocardiography).The measurement will be assessed from the data received from the health insurance provider
Time frame: From randomization to to enrollment period completion (up to 6 months)
Time to first cardiovascular-related hospitalization
Time from randomization to the first hospitalization in patients, where hospitalization is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider
Time frame: From randomization to to enrollment period completion (up to 6 months)
Time to first cardiovascular-related drug prescription
Time from randomization to the first cardiovascular-related drug prescription in patients, where drug prescription is indicated, based on the general practitioner recommendation while using PMcardio application. The measurement will be assessed from the data received from the health insurance provider
Time frame: From randomization to to enrollment period completion (up to 6 months)
Cost-effectiveness ratio and effect on cost savings
Cost-effectiveness ratio and projected effect on cost savings resulting from PMcardio remote specialist consultations measured based on Health Insurance data
Time frame: 1 year
Reliability and safety of the PMcardio measured by system up-time
The duration of time that the operating system of the application has been working and available in a reliable operating manner.
Time frame: From the very first participants randomization to total follow-up time (up to 6 months)
Reliability and safety of the PMcardio measured by system failures
The Number of failures by PMcardio application that caused the system to end abnormally.
Time frame: From the very first participants randomization to total follow-up time (up to 6 months)
General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).
The Client Satisfaction Questionnaire (CSQ-8 scale) measures general satisfaction of participating general practitioners with the functionality of the application at the end of the enrollment period. Possible scores range from 8 to 32, with higher scores indicating higher satisfaction with the application.
Time frame: From randomization to study completion (up to 1 year)
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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