Actively Recruiting

Age: 18Years +
All Genders
ID05778500

Algorithms to Improve the Accuracy of Echocardiographic Reports Using COMPACS Software Device IMPlementazione di algoRitmi di Assistenza Alla diagnOsi in un Software di Refertazione Computerizzato Che Valuta Anche l'Accuratezza Dell'Esame ECOcardiografico

Led by Istituto Auxologico Italiano · Updated on 2024-04-16

3500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

I

Istituto Auxologico Italiano

Lead Sponsor

M

Medimatic S.R.L., Genova, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how to improve the accuracy of echocardiographic reports by making them more consistent with current international guidelines and reducing diagnostic errors. This observational study focuses on whether adding automated diagnostic algorithms can help enhance the overall quality of these reports. The study is sponsored by Istituto Auxologico Italiano and aims to address important questions about diagnostic consistency during echocardiographic analysis. The study involves modifying the existing COMPACS software to include several guideline-based algorithms designed to assist clinicians in reducing diagnostic mistakes and better following clinical guidelines. This software device will be evaluated during the analysis of echocardiographic data to see if it improves diagnostic accuracy. Participants in the study have undergone clinically-indicated echocardiographic exams. Researchers will assess inconsistencies between quantitative and qualitative report parameters, as well as differences between clinical diagnoses and guideline recommendations. This will be done through analysis of the echocardiographic data collected. The study may continue until September 2026, with no additional interventions required from participants beyond data use.

CONDITIONS

Brief Title

Algorithms to Improve the Accuracy of the Echocardiographic Report

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Having undergone a clinically-indicated echocardiographic study
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Duration of echocardiographic study

Participants undergo echocardiographic studies where the COMPACS software device is used to assist clinicians by applying guideline-derived algorithms to improve report accuracy.

1 visit (in-person)

Monitoring

Duration - Up to 1 year following implementation

Participants' echocardiographic data and reports are observed and analyzed to assess inconsistencies and adherence to clinical guidelines.

Data review without additional visits

Trial Site Locations

Total: 1 location

1

Istituto Auxologico Italiano IRCCS

Milan, Italy, 20145

Actively Recruiting

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Research Team

L

Luigi Badano, MD, Ph.D.

M

Michele Tomaselli, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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