Clinical trial NCT05329246: Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
Official title: Validation of AI-assisted Clinical Assistant for Effective Management of Cardiovascular Diseases in Primary Health Care: PMcardio-1 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Medical Device
Primary Health Care
Electrocardiogram
Dyspnea
Chest Pain
Syncope
Breath Shortness
General Practitioner
Keywords: Cardiovascular Diseases
Medical Device
Primary Health Care
Diagnostic Tool
Artificial Inteligence
A.I. Clinical Assistant
Powerful Medical
PMcardio
Electrocardiogram
ECG
ECG Diagnostic
Lead sponsor: Powerful Medical
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 836
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to first cardiovascular-related consultation
timeFrame: From randomization to enrollment period completion (up to 6 months)
measure: Time to first cardiovascular-related diagnostic testing
timeFrame: From randomization to to enrollment period completion (up to 6 months)
measure: Time to first cardiovascular-related hospitalization
timeFrame: From randomization to to enrollment period completion (up to 6 months)
measure: Time to first cardiovascular-related drug prescription
timeFrame: From randomization to to enrollment period completion (up to 6 months)
Secondary outcomes:
measure: Cost-effectiveness ratio and effect on cost savings
timeFrame: 1 year
measure: Reliability and safety of the PMcardio measured by system up-time
timeFrame: From the very first participants randomization to total follow-up time (up to 6 months)
measure: Reliability and safety of the PMcardio measured by system failures
timeFrame: From the very first participants randomization to total follow-up time (up to 6 months)
measure: General practitioner satisfaction assessed by Client Satisfaction Questionnaire (CSQ-8 scale).
timeFrame: From randomization to study completion (up to 1 year)
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: MUZMED s.r.o.
city: Bidovce
country: Slovakia
facility: MAR-BID s.r.o.
city: Borský Mikuláš
country: Slovakia
facility: SIMAMED, s.r.o.
city: Bratislava
country: Slovakia
facility: SollarMED, s.r.o.
city: Búč
country: Slovakia
facility: NÁGEL, s.r.o.
city: Dolný Kubín
country: Slovakia
facility: MEDIFARMA s.r.o.
city: Hanušovce nad Topľou
country: Slovakia
facility: Promedicum, s.r.o.
city: Humenné
country: Slovakia
facility: GP Humenné, s.r.o.
city: Humenné
country: Slovakia
facility: LPSo spol. s r.o.
city: Humenné
country: Slovakia
facility: MED - AID s.r.o.
city: Hurbanovo
country: Slovakia
facility: MUDr. Peter Križalkovič
city: Kolárovo
country: Slovakia
facility: MUDr. Ildikó Papáčková
city: Komárno
country: Slovakia
facility: BELLIS-med s.r.o.
city: Komárno
country: Slovakia
facility: MEDIKONTAKT, s.r.o.
city: Košice
country: Slovakia
facility: IRS - Medicínska činnosť s.r.o.
city: Košice
country: Slovakia
facility: MUCOMED s.r.o.
city: Košice
country: Slovakia
facility: MUDr. Ján Telepovský
city: Križovany nad Dudváhom
country: Slovakia
facility: SANABITUR, s.r.o.
city: Lenartovce
country: Slovakia
facility: Anahata s.r.o.
city: Levice
country: Slovakia
facility: FONTHIS, s.r.o.
city: Martin
country: Slovakia
facility: MUDr. Mária Schmidtová, s.r.o.
city: Martin
country: Slovakia
facility: Vaša ambulancia, s. r. o.
city: Medzev
country: Slovakia
facility: MUDr. Ondrej Gajdoš
city: Medzilaborce
country: Slovakia
facility: Medic I+H s.r.o.
city: Michalovce
country: Slovakia
facility: JANMED, s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: Cardio Clinic s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: G.Praktik s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: HODOSI-MED s.r.o
city: Moldava nad Bodvou
country: Slovakia
facility: Tamice,s.r.o.
city: Nesvady
country: Slovakia
facility: TOMICI s.r.o.
city: Nitra
country: Slovakia
facility: Timimed s. r. o.
city: Nitra
country: Slovakia
facility: VERKIAD s.r.o.
city: Nitrianske Hrnčiarovce
country: Slovakia
facility: VALETUDO s.r.o.
city: Nové Zámky
country: Slovakia
facility: RODMED s.r.o.
city: Námestovo
country: Slovakia
facility: LEK - NO, s.r.o.
city: Pezinok
country: Slovakia
facility: Duo medical s.r.o.
city: Podolínec
country: Slovakia
facility: PALMED, s.r.o.
city: Poprad
country: Slovakia
facility: MEDIPRAX s.r.o
city: Poprad
country: Slovakia
facility: PULSE medicine, s.r.o
city: Prešov
country: Slovakia
facility: GP - PRAKTIK, s.r.o.
city: Prešov
country: Slovakia
facility: KNG s.r.o.
city: Prešov
country: Slovakia
facility: MDPRAK, s.r.o.
city: Prievidza
country: Slovakia
facility: RM - MEDICAL s.r.o.
city: Ruskov
country: Slovakia
facility: CorMedicus s.r.o.
city: Ružomberok
country: Slovakia
facility: Jklinik s.r.o
city: Spišský Hrušov
country: Slovakia
facility: PT Care s.r.o.
city: Stakčín
country: Slovakia
facility: MUDr. Boris Piteľ
city: Starý Tekov
country: Slovakia
facility: MEDICATEK s.r.o.
city: Strekov
country: Slovakia
facility: VINOVA Group s.r.o.
city: Tekovské Lužany
country: Slovakia
facility: GPII Medical s.r.o.
city: Veľká Lomnica
country: Slovakia
facility: MUDr. Peter MARKO, s.r.o.
city: Veľký Krtíš
country: Slovakia
facility: Resutík s.r.o.
city: Vinné
country: Slovakia
facility: MUDr. Viera Čuchranová
city: Vranov nad Topľou
country: Slovakia
facility: JOMED, spol. s r.o.
city: Štúrovo
country: Slovakia
facility: AVK MEDIC, s.r.o.
city: Želiezovce
country: Slovakia
facility: MUDr. Orság Juraj, s.r.o.
Study officials:
affiliation: Chief Scientist and Founder
name: Robert Hatala, PhD
role: PRINCIPAL_INVESTIGATOR
References: