Ultrafast Ultrasound Imaging in Pediatric Cardiology

Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Cardiac Ultrafast

About 13 in 1000 children are born with heart disease. Current tools poorly assess heart filling in children, limiting treatment. This study explores ultrafast ultrasound imaging to measure heart stiffness and perfusion in children with congenital heart disease.

Study Overview

• Status: Recruiting
• Conditions: CHD - Congenital Heart Disease
• Intervention / Treatment: Other: Cardiac Ultrafast Ultrasound

Detailed Description

About 13/1000 children are born with heart disease. As a result of better treatment, there is an increasing population of children surviving with congenital heart disease (CHD) as well as a growing number of children with obesity, hypertension and serious chronic diseases, such as cancer and kidney disease, who are at risk of developing heart disease. All of these diseases affect the heart muscle and one of the main mechanisms resulting in heart muscle damage is the development of scar tissue (fibrosis). Fibrosis makes the heart muscle stiffer and therefore more difficult to fill. The heart must fill properly with blood in order to function well; but it is very difficult to study the filling of the heart using current diagnostic tools. One of the main challenges in pediatric cardiology is that non-invasive diagnostic approaches used in adult patients to assess heart filling (diastolic function) have proven inadequate in children. This knowledge gap has limited therapeutic progress in this vulnerable population; and to date there is no effective therapy that improves the filling of the heart.

The aim of this study is to explore new potential of ultrasound to assess diastolic function in CHD children. Ultrafast ultrasound imaging (UFUS), consisting of ultrasound images at a very high rate, is a new ultrasound approach to assess cardiac function.

Using a Verasonics system (ultrasound open platform), we will assess the myocardial stiffness and the myocardial perfusion by UFUS.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Olivier VILLEMAIN, MD, PhD; Phone Number: +33 +33 5 24 54 94 79; Email: olivier.villemain@chu-bordeaux.fr

Study Locations

• France
  • France
    • Pessac, France, France, 33604
      • Recruiting
      • Hôpital Cardiologique Haut Lévêque
      • Contact: Olivier VILLEMAIN, MD,PHD; Phone Number: +33 +33 5 24 54 94 79; Email: olivier.villemain@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Every patient of CHD department of any age or any sex: 300 participants including 100 general population patients and 200 patients with CHD

Description

Inclusion Criteria:

• Every patient of CHD department of any age or any sex:

  • Patients with CHD
  • General population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale
• Social security affiliation
• Parental or legal guardian's non-opposition

Exclusion Criteria:

• Arrhythmia
• Segmental kinetic disorder.
• Pacemaker or multisite stimulation, defibrillator,
• Anechoic
• Allergy to echocardiography gel.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CHD; Patients with CHD	Other: Cardiac Ultrafast Ultrasound; Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).
General population; General population patients in good general health as evidenced by medical history coming to our department for a check-up OR diagnosed with small Atrial Septal Defect or small Patent Foramen Ovale	Other: Cardiac Ultrafast Ultrasound; Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial stiffness	assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function	Baseline
Myocardial perfusion	assessed with ultrasound data processed using the Verasonics system, to evaluate diastolic function	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic parameters	3. Echocardiographic parameters according to international guidelines for screening for structural or functional intra-cardiac abnormalities (Lopez et al. JASE. 2024) and assessed by conventional ultrasound and ultrafast ultrasound.	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): March 11, 2028
• Study Completion (Estimated): March 11, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Congenital heart disease; Paediatric; Cardiac Imaging; Ultrafast ultrasounf
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: CHUBX 2024/52; CER-BDX 2024-169 (Other Identifier: Comité d'étique - Centre Ethique et Recherche en Santé de Bordeaux)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No