NCT05329246

Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 836 (actual)
• Sponsor: Powerful Medical · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiovascular Diseases
• Medical Device
• Primary Health Care
• Electrocardiogram
• Dyspnea
• Chest Pain
• Syncope
• Breath Shortness
• General Practitioner

Interventions

Type	Name	Description
DEVICE	AI-assisted Clinical Assistant PMcardio	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.

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2022-04-14
• Last updated: 2022-08-02

Locations

56 sites across 1 country: Slovakia