Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: AI-assisted Clinical Assistant PMcardio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female aged 55 years or above. Participant is willing and able to give informed consent for participation in the study. Presenting to the GP with ANY of the following cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath. Patients insured by Dôvera ZP or Union ZP health insurance providers. Exclusion Criteria: Reason for doing the ECG at the GP clinic is a routine examination or pre-operative assessment. Participant does not present with cardiovascular symptoms: palpitations, chest pain, syncope, shortness of breath. Participant is already included in the study due to a prior GP visit throughout the trial period (e.g., participant comes for a second visit to GP clinic due to cardiovascular symptoms). Patients insured by VšZP health insurance provider Female participants who are pregnant, lactating or planning pregnancy during the study. Any other significant comorbidity, disease, or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Intervention Group<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>The usual standard of care, with NO AI-based diagnosis or treatment recommendation available. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | From randomization to to enrollment period completion (up to 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | From randomization to study completion (up to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Cardiovascular Diseases, Medical Device, Primary Health Care, Diagnostic Tool, Artificial Inteligence, A.I. Clinical Assistant, Powerful Medical, PMcardio, Electrocardiogram, ECG Diagnostic