Aortic CoarctationCT-COARCT-PEDNCT05203874
Contribution of Multimodal Imaging in Early Coarctation
An observational study of Aortic Coarctation and Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Aortic Coarctation, Congenital Heart Disease
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 29 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- age > 1 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Oscar WERNER, 467336632 ext. 33, o-werner@chu-montpellier.fr
Sophie Guillaumont, 467336632 ext. 33, s-guillaumont@chu-montpellier.fr
About this study
Official title: Contribution of Multimodal Imaging in Early Neonatal Coarctation of Aorta: CT-COARCT-PED
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
- Conditions
- Aortic Coarctation, Congenital Heart Disease
- Keywords
- Multimodal imaging, Neonatal coarctation, Radiation protection
- Medical subject headings
- Aortic Coarctation, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (2)
Level of agreement between the surgical procedure envisaged
Level of agreement between the surgical procedure envisaged after a virtual staff
Measured: day 1
Level of agreement between the surgical procedure envisaged
Level of agreement between the surgical procedure envisaged after the surgical procedure realized in real life
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion29 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar WERNER, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203874
- Sponsor's protocol ID
- RECHMPL21_0734
- Acronym
- CT-COARCT-PED
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Multimodal Imaging in Early Neonatal Coarctation of Aorta: CT-COARCT-PED
- ClinicalTrials.gov ID
- NCT05203874
- Acronym / sponsor ID
- CT-COARCT-PED / RECHMPL21_0734
- Conditions
- Aortic Coarctation, Congenital Heart Disease
- Keywords
- Multimodal imaging, Neonatal coarctation, Radiation protection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 29 Dec 2022 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- age > 1 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of all cases of neonatal coarctations
Time frame: day 1
Description of all cases of neonatal coarctations in 4 surgical centers (Bordeaux Marseille, Nantes and Toulouse) over the years 2011 to 2021
2 secondary outcomes
Level of agreement between the surgical procedure envisaged
Time frame: day 1
Level of agreement between the surgical procedure envisaged
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar WERNER, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coarctation and Congenital Heart Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar WERNER, MD (467336632 ext. 33, o-werner@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of all cases of neonatal coarctations (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.