HeartGuide: Preliminary Study

Cardiac Disease Clinical Trial

— HG-1  

Official title:

Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490303
• Other study ID #: CHUBX 2022/19
• Secondary ID: 2022-A01501-42
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: University Hospital, Bordeaux
• Contact: Stéphane LAFITTE, MD,PhD
• Phone: (0)5 57 65 64 85
• Email: stephane.lafitte[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea). The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost. Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional. The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

Description:

Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination. An algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality. Thanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients (male or female) older than 18 years,
• Patient having a scheduled cardiac ultrasound outside any emergency context,
• Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
• Subjects affiliated or benefiting from a social security plan,
• Women of childbearing age who are using effective contraception.

Exclusion Criteria:

• Person under legal protection (legal protection, guardianship or curatorship),
• Person deprived of liberty by judicial or administrative decision,
• Person who is unable to give his/her non-opposition,
• Pregnant or breastfeeding women.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Other:
• recording of the probe position
For each patient, a cardiac ultrasound acquisition will be performed with an optical tracking system (infrared) recording the probe's position in real time.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	DESKi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probe position	Difference between actual probe position and predicted position with guidance algorithm	Day 0
Secondary	Percentage of matches between algorithm and expert		Day 0