Algorithms to Improve the Accuracy of the Echocardiographic Report (IMPROVE ECO)

April 15, 2024 updated by: Istituto Auxologico Italiano

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Recruiting
        • Istituto Auxologico Italiano IRCCS
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients who consecutively undergo an echocardiographic examination

Description

Inclusion Criteria:

  • Having undergone a clinically-indicated echocardiographic study

Exclusion Criteria:

  • Denial of the consensus to use individual clinical data for research purposes

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inconsistencies between quantitative and qualitative parameters in the report
Time Frame: During analysis of echocardiographic data
Number of inconsistencies between quantitative and qualitative parameters in the report
During analysis of echocardiographic data

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inconsistencies between the clinical diagnosis and clinical guidelines
Time Frame: During analysis of echocardiographic data
Number of inconsistent clinical diagnoses in the report and indications included in current guidelines
During analysis of echocardiographic data

Collaborators and Investigators

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

Sponsor

Istituto Auxologico Italiano

Collaborators

Medimatic S.R.L., Genova, Italy

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)

September 30, 2020

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09J002

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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