Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Management of Prenatally Diagnosed Isolated Right Aortic Arch (ARCADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029064
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Congeital heart disease explorations unit - UE3C Lowendal - Paris
University Hospital, Rouen
Nantes University Hospital
University Hospital, Grenoble
University Hospital, Bordeaux
Clinique La louvère - Lille - France
University Hospital, Tours
University Hospital, Caen
Toulouse University Hospital
Hospices Civils de Lyon
Marseille University Hospital
Amiens University Hospital
Martinique University Hospital
Dijon University Hospital
Private cardiology practice, Massy
Private cardiology practice, Marseille
Private cardiology practice, Pontoise
Private cardiology practice, Strasbourg
Private cardiology practice, Brest
Private cardiology practice, Rennes
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression).

Furthermore, indications for surgery in this type of abnormalities are not well-established.

The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies.

Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome.

After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms.

The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis.

The secondary aims are :

  • to specify the association of an isolated right aortic arch with a genetic anomaly,
  • to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up,
  • to evaluate the incidence of respiratory and digestive complications in the first year of life,
  • to evaluate the indications for surgical management during the first year of life.

Condition or disease
Isolated Right Aortic Arch

Detailed Description:

Retrospective (from 2010 to 2019), multicentre, observational study carried out in the French national M3C network (complex CHD expert centers).

Patients with a prenatal diagnosis of isolated right aortic arch will be included. Patients with a right aortic arch associated with any CHD will be excluded, as well as patients whose parents refuse the use of medical data of their child.

The following data will be collected:

Clinical data:

  • Functional signs of tracheal or esophageal compression in the first year of life.
  • Association with a genetic syndrome.

Echocardiographic data:

  • Prenatal: anatomical description of the aorta and supra-aortic trunks. Position of the ductus arteriosus, presence of a thymus.
  • Postnatal: confirmation of the right aortic arch, absence of conotruncal CHD, closure of the ductus arteriosus.

If performing a chest CT scan in the first year of life:

  • Reason: systematic or on symptoms,
  • Age of realization,
  • Anatomical analysis of the aortic arches,
  • Concordance with antenatal diagnosis,
  • Evaluation of the degree of tracheal compression,
  • Screening for a vascular complication.

If performing an ante- or post-natal genetic sampling:

  • Type of sampling if antenatal: amniocentesis or trophoblast biopsy,
  • Type of analysis: karyotype, FISH, CGH array,
  • Molecular diagnosis.

If performing a surgery during the first year of life:

  • Indication: prophylactic or symptomatic,
  • Type of intervention,
  • Age at the intervention

Layout table for study information
Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis [ Time Frame: 1 day ]
    Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis


Secondary Outcome Measures :
  1. Rate of genetic anomaly with an isolated right aortic arch [ Time Frame: 1 day ]

    Incidence of genetic anomaly with an isolated right aortic arch by specifying :

    • diagnosed retained
    • type of sampling : amniocentesis, trophoblast biopsy, blood test
    • type of analysis: karyotype, FISH, CGH array

  2. Rate of realization of chest CT angiography before the first year of life with an isolated right aortic arch [ Time Frame: 1 day ]

    If performing a chest CT scan the first year of life:

    • Reason: systematic or on symptoms
    • Age of realization
    • Anatomical analysis of the aortic arches
    • Concordance with antenatal diagnosis
    • Evaluation of the degree of tracheal compression

  3. Rate of surgical repair during the first year of life after prenatal diagnosis of an isolated right aortic arch. [ Time Frame: 1 day ]

    If performing a surgery the first year of life:

    • Indication: prophylactic or symptomatic
    • Type of intervention
    • Age at the intervention

  4. Rate of respiratory and digestive complications in the first year of life. [ Time Frame: 1 day ]
    Functional signs of tracheal or esophageal compression in the first year of life.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with antenatal diagnosis of isolated right aortic arch
Criteria

Inclusion criteria:

• Prenatal diagnosis of an isolated right aortic arch

Exclusion criteria:

  • Association with any congenital heart disease according to the ACC-CHD (Orphanet) classification
  • Postnatal diagnosis of an isolated right aortic arch
  • Refusal of parents to use medical data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029064


Locations
Layout table for location information
France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Congeital heart disease explorations unit - UE3C Lowendal - Paris
University Hospital, Rouen
Nantes University Hospital
University Hospital, Grenoble
University Hospital, Bordeaux
Clinique La louvère - Lille - France
University Hospital, Tours
University Hospital, Caen
Toulouse University Hospital
Hospices Civils de Lyon
Marseille University Hospital
Amiens University Hospital
Martinique University Hospital
Dijon University Hospital
Private cardiology practice, Massy
Private cardiology practice, Marseille
Private cardiology practice, Pontoise
Private cardiology practice, Strasbourg
Private cardiology practice, Brest
Private cardiology practice, Rennes
Investigators
Layout table for investigator information
Principal Investigator: Sophie GUILLAUMONT, MD University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04029064    
Other Study ID Numbers: RECHMPL19_0146
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
right aortic arch
congenital heart disease
pediatrics
cardiology
prenatal diagnosis