Validation of PMcardio AI-assisted Clinical Assistant in Primary Care — PMCARDIO-PT1  

Cardiovascular Diseases Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05329246
• Study type: Interventional
• Source: Powerful Medical
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Completion date: June 30, 2022