ClinicalTrials.gg
Status unknownNCT05203874CT-COARCT-PEDUpdated Feb 1, 2022

Contribution of Multimodal Imaging in Early Coarctation

An observational study in Aortic Coarctation and Congenital Heart Disease, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
800
Ages
Up to 1 Year
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Aortic Coarctation
  • Congenital Heart Disease

Keywords

  • Multimodal imaging
  • Neonatal coarctation
  • Radiation protection
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In context

Aortic Coarctation

49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.

This study's planned enrollment of 800 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.

Browse Aortic Coarctation studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all newborns who have had coarctation surgery during the first month of life in one of the four center included during the period between 2011 and 2021

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

  • age > 1 years
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
800 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: day 1

Secondary outcomes

  1. Level of agreement between the surgical procedure envisaged

    Level of agreement between the surgical procedure envisaged after a virtual staff

    Time frame: day 1

  2. Level of agreement between the surgical procedure envisaged

    Level of agreement between the surgical procedure envisaged after the surgical procedure realized in real life

    Time frame: day 1

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05203874
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Jan 1, 2022
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 29, 2022 (estimated)
Last update
Feb 1, 2022

Study contacts

Oscar WERNER, MD
Contact
o-werner@chu-montpellier.fr
467336632 ext. 33
Sophie Guillaumont, MD
Contact
s-guillaumont@chu-montpellier.fr
467336632 ext. 33
Oscar WERNER, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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