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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-21-09-037810 | Other Identifier | Clinical Investigation ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Intervention Group | Experimental | 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 |
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| Control Group | No Intervention | The usual standard of care, with NO AI-based diagnosis or treatment recommendation available. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted Clinical Assistant PMcardio | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hatala, PhD | Chief Scientist and Founder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUZMED s.r.o. | Bardejov | Slovakia | ||||
| MAR-BID s.r.o. |
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| Label | URL |
|---|---|
| PMcardio Landing Page | View source |
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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) |
| Bidovce |
| Slovakia |
| SIMAMED, s.r.o. | Borský Mikuláš | Slovakia |
| SollarMED, s.r.o. | Bratislava | Slovakia |
| NÁGEL, s.r.o. | Búč | Slovakia |
| MEDIFARMA s.r.o. | Dolný Kubín | Slovakia |
| Promedicum, s.r.o. | Hanušovce nad Topľou | Slovakia |
| GP Humenné, s.r.o. | Humenné | Slovakia |
| LPSo spol. s r.o. | Humenné | Slovakia |
| MED - AID s.r.o. | Humenné | Slovakia |
| MUDr. Peter Križalkovič | Hurbanovo | Slovakia |
| MUDr. Ildikó Papáčková | Kolárovo | Slovakia |
| BELLIS-med s.r.o. | Komárno | Slovakia |
| MEDIKONTAKT, s.r.o. | Komárno | Slovakia |
| IRS - Medicínska činnosť s.r.o. | Košice | Slovakia |
| MUCOMED s.r.o. | Košice | Slovakia |
| MUDr. Ján Telepovský | Košice | 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 Hrnčiarovce | 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 |
| CorMedicus s.r.o. | Ruskov | Slovakia |
| Jklinik s.r.o | Ružomberok | Slovakia |
| PT Care s.r.o. | Spišský Hrušov | Slovakia |
| MUDr. Boris Piteľ | Stakčín | Slovakia |
| MEDICATEK s.r.o. | Starý Tekov | Slovakia |
| VINOVA Group s.r.o. | Strekov | Slovakia |
| AVK MEDIC, s.r.o. | Štúrovo | Slovakia |
| GPII Medical s.r.o. | Tekovské Lužany | Slovakia |
| MUDr. Peter MARKO, s.r.o. | Veľká Lomnica | Slovakia |
| Resutík s.r.o. | Veľký Krtíš | Slovakia |
| MUDr. Viera Čuchranová | Vinne | Slovakia |
| JOMED, spol. s r.o. | Vranov nad Topľou | Slovakia |
| MUDr. Orság Juraj, s.r.o. | Želiezovce | Slovakia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D004417 | Dyspnea |
| D002637 | Chest Pain |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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