Prognostic Role of AI-Echo

NCT ID: NCT07009639

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 and 85 years.
2. Hospitalization in CCU for acute cardiac pathology (e.g. acute coronary syndrome, acute or exacerbated heart failure, malignant arrhythmias, etc.).
3. Ability to provide written informed consent.

Exclusion Criteria

1. Severe hemodynamic instability, history to contraindicate the execution of the echocardiographic examination.
2. Severely inadequate echocardiographic window that precludes atrial or ventricular morpho-functional assessment.
3. Inability to continue the study for clinical reasons, logistics or patient refusal.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calabria

OTHER

Sponsor Role lead

Responsible Party

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Antonio Curcio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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"Annunziata" Hospital

Cosenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Curcio, Medicine

Role: CONTACT

+390984681877

Facility Contacts

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Antonio Curcio

Role: primary

+390984681877

Other Identifiers

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58/2025

Identifier Type: -

Identifier Source: org_study_id

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