IMPROVE ECO: Algorithms to Improve the Accuracy of the Echocardiographic Report
Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778500
Collaborator
Medimatic S.R.L., Genova, Italy (Other)
3,500
1
48
72.9
Study Details
Study Description
Brief 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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
3500 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
IMPlementazione di algoRitmi di Assistenza Alla diagnOsi in un Software di Refertazione Computerizzato Che Valuta Anche l'Accuratezza Dell'Esame ECOcardiografico
Actual Study Start Date
:
Sep 30, 2020
Anticipated Primary Completion Date
:
Sep 30, 2023
Anticipated Study Completion Date
:
Sep 30, 2024
Outcome Measures
Primary Outcome Measures
- Inconsistencies between quantitative and qualitative parameters in the report [During analysis of echocardiographic data]
Number of inconsistencies between quantitative and qualitative parameters in the report
Secondary Outcome Measures
- Inconsistencies between the clinical diagnosis and clinical guidelines [During analysis of echocardiographic data]
Number of inconsistent clinical diagnoses in the report and indications included in current guidelines
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Having undergone a clinically-indicated echocardiographic study
Exclusion Criteria:
- Denial of the consensus to use individual clinical data for research purposes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Auxologico Italiano IRCCS | Milan | Italy | 20145 |
Sponsors and Collaborators
- Istituto Auxologico Italiano
- Medimatic S.R.L., Genova, Italy
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05778500
Other Study ID Numbers:
- 09J002
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano