NCT05778500

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2020Sep 2026

Study Start

First participant enrolled

September 30, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

February 24, 2023

Last Update Submit

April 15, 2024

Conditions

Echocardiography

Keywords

Transthoracic echocardiographyTransesophageal echocardiographyReport

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Inconsistencies between the clinical diagnosis and clinical guidelines

    During analysis of echocardiographic data

Interventions

COMPACSDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who consecutively undergo an echocardiographic examination

You may qualify if:

  • Having undergone a clinically-indicated echocardiographic study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

Central Study Contacts

Luigi Badano, MD, Ph.D.

CONTACT

+390261911l.badano@auxologico.it

Michele Tomaselli, M.D.

CONTACT

+3902619111l.badano@auxologico.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 21, 2023

Study Start

September 30, 2020

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations

IT(1)