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NCT05778500 Clinical Trial

Algorithms to Improve the Accuracy of the Echocardiographic Report

Echocardiography Clinical Trial

— IMPROVE ECO  

Official title:
IMPlementazione di algoRitmi di Assistenza Alla diagnOsi in un Software di Refertazione Computerizzato Che Valuta Anche l'Accuratezza Dell'Esame ECOcardiografico

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05778500
Other study ID # 09J002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2020
Est. completion date September 30, 2026

Study information
Verified date April 2024
Source Istituto Auxologico Italiano
Contact Luigi Badano, MD, Ph.D.
Phone +390261911
Email l.badano@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study aims to improve the accuracy of the report of the echocardiographic study, making it more consistent with the current international guidelines and reducing the diagnostic mistakes in patients undergoing clinically -indicated echocardiography. The main questions it aims to answer are: - can the addition of automated diagnostic algorithms help to improve the overall accuracy of the echocardiographic report?

Recruitment information / eligibility
Status Recruiting
Enrollment 3500
Est. completion date September 30, 2026
Est. primary completion date September 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having undergone a clinically-indicated echocardiographic study Exclusion Criteria: - Denial of the consensus to use individual clinical data for research purposes

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• COMPACS
We will modify the current version of the COMPACS software package to implement several guideline-derived algorithms to help the clinician to reduce diagnostic errors and increase the adherence to current guidelines

Locations
Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan

Sponsors (2)
Lead Sponsor Collaborator
Istituto Auxologico Italiano Medimatic S.R.L., Genova, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inconsistencies between quantitative and qualitative parameters in the report Number of inconsistencies between quantitative and qualitative parameters in the report During analysis of echocardiographic data
Secondary Inconsistencies between the clinical diagnosis and clinical guidelines Number of inconsistent clinical diagnoses in the report and indications included in current guidelines During analysis of echocardiographic data
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