HeartGuide: Preliminary Study (HG-1)

October 13, 2022 updated by: University Hospital, Bordeaux

Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients
Patient with an echocardiography examination
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probe position
Time Frame: Day 0
Difference between actual probe position and predicted position with guidance algorithm
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of matches between algorithm and expert
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

DESKi

Investigators

  • Study Director: Stéphane LAFITTE, MD,PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (ACTUAL)

August 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/19
  • 2022-A01501-42 (OTHER: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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