Validation of an Artificial Intelligence Algorithm Identifying Echocardiographic Reference Views. Ultrasound - Cardiac Acquisition Guide

NCT05265585 | Completed

• 1 other identifier: CHUBX 2020/02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Echocardiography is the examination of choice for the study of cardiac pathologies. Beyond its use by cardiologists, the interest of echocardiography for other medical specialties has already been demonstrated, in particular in intensive care in the case of haemodynamic failure, or in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnoea. Echocardiography also plays a major role in screening for heart disease, particularly valvular heart disease. In countries with very limited access to echocardiography, there is a major under-diagnosis of heart valve disease, including rheumatic fever, which affects 30 million people and causes 305,000 deaths worldwide. As this is a global public health problem, recommendations were drafted in 2012 to organise and facilitate echocardiographic screening of populations at risk. The expansion of the use of echocardiography has been catalysed by the miniaturisation of ultrasound systems and the reduction in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost. It is therefore possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional. In order to be effective, the last limit to this democratisation is the training, and in particular that of non-specialists (i.e. non-cardiologists). Echocardiography remains an examination that requires anatomical knowledge and practice. Performing an echocardiogram involves visualising the heart from different points on the chest. The three main points are in the left paraspinal area, at the apex of the heart and under the sternum. From these areas, the operator must obtain several reference views which are strictly defined in order to be able to correctly observe the different cardiac structures and make comparable measurements from one examination and clinician to another. It is therefore necessary first of all to learn how to handle the probe and to be able to obtain the reference views. The morphology of the patient, the shape of the thorax, the exact position of the heart, the movements of the heart according to the position of the patient and his breathing are all elements to be taken into account and make each examination different from the previous one.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of algorithm - cardiologist concordance

  Measured by the percentage of images for which the labelling of the algorithm and the labelling of the cardiologist are identical. This percentage is calculated per examination.

  Day 0

Study Arms (1)

Echocardiography group

Diagnostic Test: Ultrasound - Cardiac Acquisition

Interventions

Ultrasound - Cardiac Acquisition DIAGNOSTIC_TEST

The evaluation of the algorithm takes place on patients with an indication for echocardiography. This examination is done in a standard way with the potential specific explorations related to the indication of the examination. During the echocardiography, the operator records the search phase for the following reference views: * Parasternal window (Parasternal long axis, Parasternal minor axis) * Apical window (Apical 4 cavities, Apical 3 cavities, Apical 2 cavities * Sub costal window, Sub costal 4 cavities, Inferior vena cava)

Echocardiography group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in the study are adult patients having an echocardiography programmed in the echocardiography laboratory of the Bordeaux University Hospital.

You may qualify if:

• Patients (male or female) over 18 years of age,
• Patient having an echocardiography examination scheduled at the echocardiography laboratory of the Bordeaux University Hospital,
• Subjects affiliated to or benefiting from a social security scheme,
• Women of childbearing age benefiting from effective contraception.

You may not qualify if:

• Person subject to a legal protection measure (safeguard of justice, guardianship or curators),
• Person deprived of liberty by judicial or administrative decision,
• Person who is unable to give his/her non-opposition,
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Stéphane LAFITTE, MD PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Bertrand MOAL

  DESKi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: June 19, 2020
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

FR (1)