Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

Cardiovascular Diseases Clinical Trial

— PMCARDIO-PT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329246
• Other study ID #: 202106001
• Secondary ID: CIV-21-09-037810
• Status: Completed
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Powerful Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 836
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Slovakia	AVK MEDIC, s.r.o.	Štúrovo
Slovakia	MUDr. Orság Juraj, s.r.o.	Želiezovce
Slovakia	MUZMED s.r.o.	Bardejov
Slovakia	MAR-BID s.r.o.	Bidovce
Slovakia	SIMAMED, s.r.o.	Borský Mikuláš
Slovakia	SollarMED, s.r.o.	Bratislava
Slovakia	NÁGEL, s.r.o.	Búc
Slovakia	MEDIFARMA s.r.o.	Dolný Kubín
Slovakia	Promedicum, s.r.o.	Hanušovce nad Toplou
Slovakia	GP Humenné, s.r.o.	Humenné
Slovakia	LPSo spol. s r.o.	Humenné
Slovakia	MED - AID s.r.o.	Humenné
Slovakia	MUDr. Peter Križalkovic	Hurbanovo
Slovakia	IRS - Medicínska cinnost s.r.o.	Košice
Slovakia	MUCOMED s.r.o.	Košice
Slovakia	MUDr. Ján Telepovský	Košice
Slovakia	MUDr. Ildikó Papácková	Kolárovo
Slovakia	BELLIS-med s.r.o.	Komárno
Slovakia	MEDIKONTAKT, s.r.o.	Komárno
Slovakia	SANABITUR, s.r.o.	Križovany nad Dudváhom
Slovakia	Anahata s.r.o.	Lenartovce
Slovakia	FONTHIS, s.r.o.	Levice
Slovakia	MUDr. Mária Schmidtová, s.r.o.	Martin
Slovakia	Vaša ambulancia, s. r. o.	Martin
Slovakia	MUDr. Ondrej Gajdoš	Medzev
Slovakia	Medic I+H s.r.o.	Medzilaborce
Slovakia	JANMED, s.r.o.	Michalovce
Slovakia	Cardio Clinic s.r.o.	Moldava nad Bodvou
Slovakia	G.Praktik s.r.o.	Moldava nad Bodvou
Slovakia	HODOSI-MED s.r.o	Moldava nad Bodvou
Slovakia	Tamice,s.r.o.	Moldava nad Bodvou
Slovakia	LEK - NO, s.r.o.	Námestovo
Slovakia	TOMICI s.r.o.	Nesvady
Slovakia	Timimed s. r. o.	Nitra
Slovakia	VERKIAD s.r.o.	Nitra
Slovakia	VALETUDO s.r.o.	Nitrianske Hrnciarovce
Slovakia	RODMED s.r.o.	Nové Zámky
Slovakia	Duo medical s.r.o.	Pezinok
Slovakia	PALMED, s.r.o.	Podolínec
Slovakia	MEDIPRAX s.r.o	Poprad
Slovakia	PULSE medicine, s.r.o	Poprad
Slovakia	GP - PRAKTIK, s.r.o.	Prešov
Slovakia	KNG s.r.o.	Prešov
Slovakia	MDPRAK, s.r.o.	Prešov
Slovakia	RM - MEDICAL s.r.o.	Prievidza
Slovakia	Jklinik s.r.o	Ružomberok
Slovakia	CorMedicus s.r.o.	Ruskov
Slovakia	PT Care s.r.o.	Spišský Hrušov
Slovakia	MUDr. Boris Pitel	Stakcín
Slovakia	MEDICATEK s.r.o.	Starý Tekov
Slovakia	VINOVA Group s.r.o.	Strekov
Slovakia	GPII Medical s.r.o.	Tekovské Lužany
Slovakia	MUDr. Peter MARKO, s.r.o.	Velká Lomnica
Slovakia	Resutík s.r.o.	Velký Krtíš
Slovakia	MUDr. Viera Cuchranová	Vinné
Slovakia	JOMED, spol. s r.o.	Vranov nad Toplou

Sponsors (1)

Lead Sponsor	Collaborator
Powerful Medical

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   PMcardio Landing Page