- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490303
HeartGuide: Preliminary Study (HG-1)
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients
Patient with an echocardiography examination
|
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
Sponsor
Collaborators
Investigators
- Study Director: Stéphane LAFITTE, MD,PhD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2022/19
- 2022-A01501-42 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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