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

July 29, 2022 updated by: Powerful Medical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
836

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bardejov, Slovakia
        • MUZMED s.r.o.
      • Bidovce, Slovakia
        • MAR-BID s.r.o.
      • Borský Mikuláš, Slovakia
        • SIMAMED, s.r.o.
      • Bratislava, Slovakia
        • SollarMED, s.r.o.
      • Búč, Slovakia
        • NÁGEL, s.r.o.
      • Dolný Kubín, Slovakia
        • MEDIFARMA s.r.o.
      • Hanušovce nad Topľou, Slovakia
        • Promedicum, s.r.o.
      • Humenné, Slovakia
        • GP Humenné, s.r.o.
      • Humenné, Slovakia
        • LPSo spol. s r.o.
      • Humenné, Slovakia
        • MED - AID s.r.o.
      • Hurbanovo, Slovakia
        • MUDr. Peter Križalkovič
      • Kolárovo, Slovakia
        • MUDr. Ildikó Papáčková
      • Komárno, Slovakia
        • BELLIS-med s.r.o.
      • Komárno, Slovakia
        • MEDIKONTAKT, s.r.o.
      • Košice, Slovakia
        • IRS - Medicínska činnosť s.r.o.
      • Košice, Slovakia
        • MUCOMED s.r.o.
      • Košice, Slovakia
        • MUDr. Ján Telepovský
      • Križovany nad Dudváhom, Slovakia
        • SANABITUR, s.r.o.
      • Lenartovce, Slovakia
        • Anahata s.r.o.
      • Levice, Slovakia
        • FONTHIS, s.r.o.
      • Martin, Slovakia
        • MUDr. Mária Schmidtová, s.r.o.
      • Martin, Slovakia
        • Vaša ambulancia, s. r. o.
      • Medzev, Slovakia
        • MUDr. Ondrej Gajdoš
      • Medzilaborce, Slovakia
        • Medic I+H s.r.o.
      • Michalovce, Slovakia
        • JANMED, s.r.o.
      • Moldava nad Bodvou, 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.
      • Nesvady, Slovakia
        • TOMICI s.r.o.
      • Nitra, Slovakia
        • Timimed s. r. o.
      • Nitra, Slovakia
        • VERKIAD s.r.o.
      • Nitrianske Hrnčiarovce, Slovakia
        • VALETUDO s.r.o.
      • Nové Zámky, Slovakia
        • RODMED s.r.o.
      • Námestovo, Slovakia
        • LEK - NO, s.r.o.
      • Pezinok, Slovakia
        • Duo medical s.r.o.
      • Podolínec, Slovakia
        • PALMED, s.r.o.
      • Poprad, Slovakia
        • MEDIPRAX s.r.o
      • Poprad, Slovakia
        • PULSE medicine, s.r.o
      • Prešov, Slovakia
        • GP - PRAKTIK, s.r.o.
      • Prešov, Slovakia
        • KNG s.r.o.
      • Prešov, Slovakia
        • MDPRAK, s.r.o.
      • Prievidza, Slovakia
        • RM - MEDICAL s.r.o.
      • Ruskov, Slovakia
        • CorMedicus s.r.o.
      • Ružomberok, Slovakia
        • Jklinik s.r.o
      • Spišský Hrušov, Slovakia
        • PT Care s.r.o.
      • Stakčín, Slovakia
        • MUDr. Boris Piteľ
      • Starý Tekov, Slovakia
        • MEDICATEK s.r.o.
      • Strekov, Slovakia
        • VINOVA Group s.r.o.
      • Tekovské Lužany, Slovakia
        • GPII Medical s.r.o.
      • Veľká Lomnica, Slovakia
        • MUDr. Peter MARKO, s.r.o.
      • Veľký Krtíš, Slovakia
        • Resutík s.r.o.
      • Vinné, Slovakia
        • MUDr. Viera Čuchranová
      • Vranov nad Topľou, Slovakia
        • JOMED, spol. s r.o.
      • Štúrovo, Slovakia
        • AVK MEDIC, s.r.o.
      • Želiezovce, Slovakia
        • MUDr. Orság Juraj, s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental Intervention Group
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
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.
NO_INTERVENTION: Control Group
The usual standard of care, with NO AI-based diagnosis or treatment recommendation available.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first cardiovascular-related consultation
Time Frame: From randomization to enrollment period completion (up to 6 months)
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 Frame: From randomization to to enrollment period completion (up to 6 months)
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 Frame: From randomization to to enrollment period completion (up to 6 months)
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 Frame: From randomization to to enrollment period completion (up to 6 months)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost-effectiveness ratio and effect on cost savings
Time Frame: 1 year
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
Time Frame: From the very first participants randomization to total follow-up time (up to 6 months)
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
Time Frame: From the very first participants randomization to total follow-up time (up to 6 months)
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).
Time Frame: From randomization to study completion (up to 1 year)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Powerful Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Hatala, PhD, Chief Scientist and Founder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202106001
  • CIV-21-09-037810 (OTHER: Clinical Investigation ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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