Atrial CardiomyopathyNCT07009639
Prognostic Role of AI-Echo
An observational study of Atrial Cardiomyopathy, run by University of Calabria at 1 site in Italy.
Trial summary
Left atrial cardiomyopathy (LACM) is frequently underdiagnosed but plays a key role in increasing the risk of atrial fibrillation (AF) and thromboembolic events. While atrial strain is a validated marker of LACM, its measurement with conventional echocardiography can be time-consuming and less feasible in acute… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Cardiomyopathy
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-85 years, in sinus rhythm at the time of enrollment, with an indication for echocardiography for acute cardiac pathology.
Who may be able to join
- Age between 18 and 85 years.
- Hospitalization in CCU for acute cardiac pathology (e.g. acute coronary syndrome, acute or exacerbated heart failure, malignant arrhythmias, etc.).
- Ability to provide written informed consent.
Who cannot join
- Severe hemodynamic instability, history to contraindicate the execution of the echocardiographic examination.
- Severely inadequate echocardiographic window that precludes atrial or ventricular morpho-functional assessment.
- Inability to continue the study for clinical reasons, logistics or patient refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Annunziata" Hospital
Cosenza, 87100
Antonio Curcio, +390984681877, antonio.curcio.cardio@unical.it
Letizia R Romano
About this study
Official title: Evaluation of Artificial Intelligence-Assisted Echocardiography (AI-echo) in the Early Diagnosis and Prognostic Stratification of Left Atrial Cardiomyopathy (LACM) in Patients With Acute Cardiac Disease
Left atrial cardiomyopathy (LACM) is frequently underdiagnosed but plays a key role in increasing the risk of atrial fibrillation (AF) and thromboembolic events. While atrial strain is a validated marker of LACM, its measurement with conventional echocardiography can be time-consuming and less feasible in acute settings. The use of AI-assisted echocardiography (AI-echo) may help streamline image acquisition and analysis, offering faster and potentially more accurate assessment.
This study aims to compare the time required for atrial strain analysis using AI-echo versus standard methods. It also explores how changes in strain parameters (LASr, LASct, LAScd) relate to the onset of AF and in-hospital adverse outcomes, adjusting for comorbidities and conventional echo variables.
Main endpoints include time reduction with AI-echo and the association between strain changes and AF, complications, or mortality during hospitalization.
- Conditions
- Atrial Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic acquisition times changes
To compare the duration of echocardiographic image acquisition and atrial strain analysis using an AI-assisted echocardiography software versus the conventional manual method in patients admitted to the Cardiac Intensive Care Unit (CCU). All measurements will be performed using the same ecocardiography machine and by the same operator to ensure consistency. The outcome will be assessed by measuring the time (in minutes) required to complete image acquisition and atrial strain analysis with each method.
Measured: From the start of echocardiographic acquisition to the completion of atrial strain analysis
Change in left atrial reservoir strain (LASr) between admission and discharge
To assess the variation in left atrial reservoir strain (LASr), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Measured: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
Change in left atrial conduit strain (LAScd) between admission and discharge
To assess the variation in left atrial conduit strain (LAScd), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Measured: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
Change in left atrial contractile strain (LASct) between admission and discharge Description
To assess the variation in left atrial contractile strain (LASct), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Measured: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
Correlation between atrial strain variation (ΔLASr, ΔLASct, ΔLAScd) and in-hospital heart failure worsening
To evaluate whether changes in atrial strain parameters (ΔLASr, ΔLASct, ΔLAScd), measured via speckle-tracking echocardiography, correlate with the incidence of in-hospital worsening of heart failure (Unit of Measure: % of patients with in-hospital worsening heart failure). Worsening is defined as the need for intensification of diuretic therapy, initiation of inotropes, transfer to higher-level care, or an increase in NT-proBNP levels compared to baseline (measured in pg/mL).
Measured: From admission (within 24 hours of enrollment) to discharge (within 24 hours before discharge)
Secondary outcomes (3)
Incidence of in-hospital procedural complications
To assess the incidence of complications (% of patients with at least one procedural complication) related to diagnostic or interventional procedures during hospitalization, including but not limited to pericardial effusion, vascular access complications, and device-related issues. Events will be recorded based on clinical documentation and adjudicated by the clinical team.
Measured: Through study completion, an average of 7 days
Incidence of in-hospital infections
To assess the incidence of infections acquired during hospitalization (% of patients with at least one in-hospital infection), defined by clinical diagnosis supported by laboratory/microbiological findings and initiation of antimicrobial therapy.
Measured: Through study completion, an average of 7 days
Incidence of in-hospital thromboembolic events
To assess the incidence of thromboembolic events (% of patients with at least one thromboembolic event) during hospitalization, including ischemic stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism, confirmed by imaging and/or laboratory criteria.
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial CardiomyopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009639
- Sponsor's protocol ID
- 58/2025
- Status last verified
- Aug 2025
- First submitted
- 15 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence-Assisted Echocardiography (AI-echo) in the Early Diagnosis and Prognostic Stratification of Left Atrial Cardiomyopathy (LACM) in Patients With Acute Cardiac Disease
- ClinicalTrials.gov ID
- NCT07009639
- Acronym / sponsor ID
- 58/2025
- Conditions
- Atrial Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 6 Jun 2025 (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.
Left atrial cardiomyopathy (LACM) is frequently underdiagnosed but plays a key role in increasing the risk of atrial fibrillation (AF) and thromboembolic events. While atrial strain is a validated marker of LACM, its measurement with conventional echocardiography can be time-consuming and less feasible in acute settings. The use of AI-assisted echocardiography (AI-echo) may help streamline image acquisition and analysis, offering faster and potentially more accurate assessment.
This study aims to compare the time required for atrial strain analysis using AI-echo versus standard methods. It also explores how changes in strain parameters (LASr, LASct, LAScd) relate to the onset of AF and in-hospital adverse outcomes, adjusting for comorbidities and conventional echo variables.
Main endpoints include time reduction with AI-echo and the association between strain changes and AF, complications, or mortality during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-85 years, in sinus rhythm at the time of enrollment, with an indication for echocardiography for acute cardiac pathology.
Key inclusion criteria (3 listed)
- Age between 18 and 85 years.
- Hospitalization in CCU for acute cardiac pathology (e.g. acute coronary syndrome, acute or exacerbated heart failure, malignant arrhythmias, etc.).
- Ability to provide written informed consent.
Key exclusion criteria (3 listed)
- Severe hemodynamic instability, history to contraindicate the execution of the echocardiographic examination.
- Severely inadequate echocardiographic window that precludes atrial or ventricular morpho-functional assessment.
- Inability to continue the study for clinical reasons, logistics or patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Echocardiographic acquisition times changes
Time frame: From the start of echocardiographic acquisition to the completion of atrial strain analysis
To compare the duration of echocardiographic image acquisition and atrial strain analysis using an AI-assisted echocardiography software versus the conventional manual method in patients admitted to the Cardiac Intensive Care Unit (CCU). All measurements will be performed using the same ecocardiography machine and by the same operator to ensure consistency. The outcome will be assessed by measuring the time (in minutes) required to complete image acquisition and atrial strain analysis with each method.
Change in left atrial reservoir strain (LASr) between admission and discharge
Time frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
To assess the variation in left atrial reservoir strain (LASr), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Change in left atrial conduit strain (LAScd) between admission and discharge
Time frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
To assess the variation in left atrial conduit strain (LAScd), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Change in left atrial contractile strain (LASct) between admission and discharge Description
Time frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
To assess the variation in left atrial contractile strain (LASct), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.
Correlation between atrial strain variation (ΔLASr, ΔLASct, ΔLAScd) and in-hospital heart failure worsening
Time frame: From admission (within 24 hours of enrollment) to discharge (within 24 hours before discharge)
To evaluate whether changes in atrial strain parameters (ΔLASr, ΔLASct, ΔLAScd), measured via speckle-tracking echocardiography, correlate with the incidence of in-hospital worsening of heart failure (Unit of Measure: % of patients with in-hospital worsening heart failure). Worsening is defined as the need for intensification of diuretic therapy, initiation of inotropes, transfer to higher-level care, or an increase in NT-proBNP levels compared to baseline (measured in pg/mL).
3 secondary outcomes
Incidence of in-hospital procedural complications
Time frame: Through study completion, an average of 7 days
Incidence of in-hospital infections
Time frame: Through study completion, an average of 7 days
Incidence of in-hospital thromboembolic events
Time frame: Through study completion, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Atrial Cardiomyopathy, run by University of Calabria 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Curcio, Medicine (+390984681877, antonio.curcio.cardio@unical.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic acquisition times changes (time frame: From the start of echocardiographic acquisition to the completion of atrial strain analysis). The study lists 5 primary outcomes in all. 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 11 Aug 2025.