Status:
COMPLETED
Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
Lead Sponsor:
Powerful Medical
Conditions:
Cardiovascular Diseases
Medical Device
Eligibility:
All Genders
55+ years
Phase:
NA
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 compare...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
836 Patients enrolled
Trial Details
Trial ID
NCT05329246
Start Date
November 22 2021
End Date
June 30 2022
Last Update
August 2 2022
Active Locations (56)
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1
MUZMED s.r.o.
Bardejov, Slovakia
2
MAR-BID s.r.o.
Bidovce, Slovakia
3
SIMAMED, s.r.o.
Borský Mikuláš, Slovakia
4
SollarMED, s.r.o.
Bratislava, Slovakia