Contribution of Multimodal Imaging in Early Coarctation

Congenital Heart Disease Clinical Trial

— CT-COARCT-PED  

Official title:

Contribution of Multimodal Imaging in Early Neonatal Coarctation of Aorta: CT-COARCT-PED

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203874
• Other study ID #: RECHMPL21_0734
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 29, 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Montpellier
• Contact: Oscar WERNER, MD
• Phone: 467336632
• Email: o-werner[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

Description:

Coarctation of the aorta is one of the most common congenital heart diseases (5 to 8%). This heart disease can clinically result in two major clinical presentation: a neonatal form, early and potentially severe, which will require urgent care. And a later form, the discovery of which may be fortuitous. Even in it neonatal presentation, aortic coarctation will not occur during the pregnancy. But the performance of prenatal screening makes it possible to predict a "risk of coarctation" based on criteria that have been clarified with practice and time. (hypoplasia of the left cavities, isthmus / canal ratio etc.) Surgically, there are multiple techniques that will take into account the anatomy of the aortic arch and whether or not it is hypoplastic, the associated heart defects and the patient's characteristics. The choice of this surgical technique is one of the predominant elements of the future prognosis of this heart disease (recoarctation, arterial hypertension, etc.) It is in this context that the contribution of multimodal imaging (echocardiography, angiography CT scan and cardiac MRI), can be a determining element in the choice made by the surgeon of the aortic plastic surgery technique, by detailing the anatomical but also hemodynamic specificities Despite the lack of technical difficulty in performing a cardiac ultrasound in a newborn or an infant, the use of a cross sectional imaging (as CT angiography) is common in order to obtain a more comprehensive assessment of the aortic arch using 2D or 3D reconstruction techniques.

However, current practices in terms of radiation protection encourage us to limit the irradiation of our patients especially if the are to be expose potentially repeatedly to radiation during their medical care.

Thus, this multicenter study aims to clarify the role of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 29, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion criteria:

• Patients <1 years old

• Aortic coarctation in the first year of life

• Surgical management in one of the four participating centers

• No associated heart defect

Exclusion criteria

• age > 1 years

Related Conditions & MeSH terms

• Aortic Coarctation
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of all cases of neonatal coarctations	Description of all cases of neonatal coarctations in 4 surgical centers (Bordeaux Marseille, Nantes and Toulouse) over the years 2011 to 2021	day 1
Secondary	Level of agreement between the surgical procedure envisaged	Level of agreement between the surgical procedure envisaged after a virtual staff	day 1
Secondary	Level of agreement between the surgical procedure envisaged	Level of agreement between the surgical procedure envisaged after the surgical procedure realized in real life	day 1