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Cardiovascular DiseasesPMCARDIO-PT1NCT05329246

Validation of PMcardio AI-assisted Clinical Assistant in Primary Care

A study testing AI-assisted Clinical Assistant PMcardio in people with Cardiovascular Diseases and Medical Device, run by Powerful Medical at 56 sites in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
AI-assisted Clinical Assistant PMcardio
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
836 participants
Where
56 sitesSlovakia
Study dates
22 Nov 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

Slovakia56 sites

  • MUZMED s.r.o.

    Bardejov

  • MAR-BID s.r.o.

    Bidovce

  • SIMAMED, s.r.o.

    Borský Mikuláš

  • SollarMED, s.r.o.

    Bratislava

  • NÁGEL, s.r.o.

    Búč

  • MEDIFARMA s.r.o.

    Dolný Kubín

  • Promedicum, s.r.o.

    Hanušovce nad Topľou

  • GP Humenné, s.r.o.

    Humenné

  • LPSo spol. s r.o.

    Humenné

  • MED - AID s.r.o.

    Humenné

  • MUDr. Peter Križalkovič

    Hurbanovo

  • MUDr. Ildikó Papáčková

    Kolárovo

  • BELLIS-med s.r.o.

    Komárno

  • MEDIKONTAKT, s.r.o.

    Komárno

  • IRS - Medicínska činnosť s.r.o.

    Košice

  • MUCOMED s.r.o.

    Košice

  • MUDr. Ján Telepovský

    Košice

  • SANABITUR, s.r.o.

    Križovany Nad Dudváhom

  • Anahata s.r.o.

    Lenartovce

  • FONTHIS, s.r.o.

    Levice

  • MUDr. Mária Schmidtová, s.r.o.

    Martin

  • Vaša ambulancia, s. r. o.

    Martin

  • MUDr. Ondrej Gajdoš

    Medzev

  • Medic I+H s.r.o.

    Medzilaborce

  • JANMED, s.r.o.

    Michalovce

  • Cardio Clinic s.r.o.

    Moldava nad Bodvou

  • G.Praktik s.r.o.

    Moldava nad Bodvou

  • HODOSI-MED s.r.o

    Moldava nad Bodvou

  • Tamice,s.r.o.

    Moldava nad Bodvou

  • LEK - NO, s.r.o.

    Námestovo

  • TOMICI s.r.o.

    Nesvady

  • Timimed s. r. o.

    Nitra

  • VERKIAD s.r.o.

    Nitra

  • VALETUDO s.r.o.

    Nitrianske Hrnčiarovce

  • RODMED s.r.o.

    Nové Zámky

  • Duo medical s.r.o.

    Pezinok

  • PALMED, s.r.o.

    Podolínec

  • MEDIPRAX s.r.o

    Poprad

  • PULSE medicine, s.r.o

    Poprad

  • GP - PRAKTIK, s.r.o.

    Prešov

  • KNG s.r.o.

    Prešov

  • MDPRAK, s.r.o.

    Prešov

  • RM - MEDICAL s.r.o.

    Prievidza

  • CorMedicus s.r.o.

    Ruskov

  • Jklinik s.r.o

    Ružomberok

  • PT Care s.r.o.

    Spišský Hrušov

  • MUDr. Boris Piteľ

    Stakčín

  • MEDICATEK s.r.o.

    Starý Tekov

  • VINOVA Group s.r.o.

    Strekov

  • AVK MEDIC, s.r.o.

    Štúrovo

  • GPII Medical s.r.o.

    Tekovské Lužany

  • MUDr. Peter MARKO, s.r.o.

    Veľká Lomnica

  • Resutík s.r.o.

    Veľký Krtíš

  • MUDr. Viera Čuchranová

    Vinne

  • JOMED, spol. s r.o.

    Vranov nad Topľou

  • MUDr. Orság Juraj, s.r.o.

    Želiezovce

Other trials in Slovakia

About this study

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

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.

Read the 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.

Being tested
AI-assisted Clinical Assistant PMcardio
Keywords
Cardiovascular Diseases, Medical Device, Primary Health Care, Diagnostic Tool, Artificial Inteligence, A.I. Clinical Assistant, Powerful Medical, PMcardio, Electrocardiogram, ECG, ECG Diagnostic
Medical subject headings
Cardiovascular Diseases, Dyspnea, Chest Pain, Syncope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-assisted Clinical Assistant PMcardioDevice

    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.

Study groups in NCT05329246
Study groupRoleWhat they receive
Experimental Intervention GroupExperimentalAI-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
Receives: Device: AI-assisted Clinical Assistant PMcardio
Control GroupNo interventionThe usual standard of care, with NO AI-based diagnosis or treatment recommendation available.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to enrollment period completion (up to 6 months)

  2. 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

    Measured: From randomization to to enrollment period completion (up to 6 months)

  3. 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

    Measured: From randomization to to enrollment period completion (up to 6 months)

  4. 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

    Measured: From randomization to to enrollment period completion (up to 6 months)

Secondary outcomes (4)

  1. 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

    Measured: 1 year

  2. 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.

    Measured: From the very first participants randomization to total follow-up time (up to 6 months)

  3. Reliability and safety of the PMcardio measured by system failures

    The Number of failures by PMcardio application that caused the system to end abnormally.

    Measured: From the very first participants randomization to total follow-up time (up to 6 months)

  4. 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.

    Measured: From randomization to study completion (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start22 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
836 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329246
Sponsor's protocol ID
202106001
Other IDs
CIV-21-09-037810
Acronym
PMCARDIO-PT1
Status last verified
Jul 2022
First submitted
13 Dec 2021
Last updated
2 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-assisted Clinical Assistant PMcardio in people with Cardiovascular Diseases and Medical Device, run by Powerful Medical at 56 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first cardiovascular-related consultation (time frame: From randomization to enrollment period completion (up to 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.

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