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RecruitingNCT05778500IMPROVE ECOUpdated Apr 16, 2024

Algorithms to Improve the Accuracy of the Echocardiographic Report

An observational study in Echocardiography, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
3,500
Ages
18 Years and older
Sex
All
01

Study 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?
02

Conditions studied

  • Echocardiography

Keywords

  • Transthoracic echocardiography
  • Transesophageal echocardiography
  • Report
03

In context

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients who consecutively undergo an echocardiographic examination

Inclusion criteria

  • Having undergone a clinically-indicated echocardiographic study

Exclusion criteria

Exclusion Criteria:

  • Denial of the consensus to use individual clinical data for research purposes
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
3,500 participants (estimated)
Patient registry
No

Interventions

  • DeviceCOMPACS

    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

06

What researchers measure

Primary outcomes

  1. Inconsistencies between quantitative and qualitative parameters in the report

    Number of inconsistencies between quantitative and qualitative parameters in the report

    Time frame: During analysis of echocardiographic data

Secondary outcomes

  1. Inconsistencies between the clinical diagnosis and clinical guidelines

    Number of inconsistent clinical diagnoses in the report and indications included in current guidelines

    Time frame: During analysis of echocardiographic data

07

Study locations

1 of 1 sites recruiting
  • Istituto Auxologico Italiano IRCCS
    Milan, 20145, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05778500
Lead sponsor
Istituto Auxologico Italiano
Collaborators
Medimatic S.R.L., Genova, Italy
Responsible party
Sponsor
First posted
Mar 21, 2023
Start date
Sep 30, 2020
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 16, 2024

Study contacts

Luigi Badano, MD, Ph.D.
Contact
l.badano@auxologico.it
+390261911 ext. 2319
Michele Tomaselli, M.D.
Contact
l.badano@auxologico.it
+3902619111 ext. 2319

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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