Contribution of Multimodal Imaging in Early Coarctation

NCT ID: NCT05203874

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-29

Brief 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

Detailed 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

Conditions

Aortic Coarctation; Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oscar WERNER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Oscar WERNER, MD

Role: CONTACT

o-werner@chu-montpellier.fr

467336632 ext. 33

Sophie Guillaumont, MD

Role: CONTACT

s-guillaumont@chu-montpellier.fr

467336632 ext. 33

Facility Contacts

Oscar WERNER

Role: primary

o-werner@chu-montpellier.fr

467336632 ext. 33

Sophie Guillaumont

Role: backup

s-guillaumont@chu-montpellier.fr

467336632 ext. 33

Other Identifiers

RECHMPL21_0734

Identifier Type: -

Identifier Source: org_study_id