EchocardiographyIMPROVE ECONCT05778500
Algorithms to Improve the Accuracy of the Echocardiographic Report
An observational study of Echocardiography, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography
- What is being tested?
- COMPACS
- Type of treatment
- Medical device
- How many people
- 3,500 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2020to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who consecutively undergo an echocardiographic examination
Who may be able to join
- Having undergone a clinically-indicated echocardiographic study
Who cannot join
- Denial of the consensus to use individual clinical data for research purposes
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, 20145
Luigi Badano, PhD, +390261911 ext. 2319, l.badano@auxologico.it
About this study
Official title: 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?
- Conditions
- Echocardiography
- Being tested
- COMPACS
- Keywords
- Transthoracic echocardiography, Transesophageal echocardiography, Report
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Inconsistencies between quantitative and qualitative parameters in the report
Number of inconsistencies between quantitative and qualitative parameters in the report
Measured: 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
Measured: During analysis of echocardiographic data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start30 Sep 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Medimatic S.R.L., Genova, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778500
- Sponsor's protocol ID
- 09J002
- Acronym
- IMPROVE ECO
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPlementazione di algoRitmi di Assistenza Alla diagnOsi in un Software di Refertazione Computerizzato Che Valuta Anche l'Accuratezza Dell'Esame ECOcardiografico
- ClinicalTrials.gov ID
- NCT05778500
- Acronym / sponsor ID
- IMPROVE ECO / 09J002
- Conditions
- Echocardiography
- Keywords
- Transthoracic echocardiography, Transesophageal echocardiography, Report
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Medimatic S.R.L., Genova, Italy
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who consecutively undergo an echocardiographic examination
Key inclusion criteria (1 listed)
- Having undergone a clinically-indicated echocardiographic study
Key exclusion criteria (1 listed)
- Denial of the consensus to use individual clinical data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMPACSWe 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 | Device | – |
Primary outcome
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
1 secondary outcome
Inconsistencies between the clinical diagnosis and clinical guidelines
Time frame: During analysis of echocardiographic data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Related trials for Echocardiography
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Heart Failure
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Badano, MD, Ph.D. (+390261911 ext. 2319, l.badano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inconsistencies between quantitative and qualitative parameters in the report (time frame: During analysis of echocardiographic data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.