Isolated Right Aortic Arch Clinical Trial
— ARCADEOfficial title:
Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study
| Verified date | March 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 1 Year |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Uh Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Amiens University Hospital, Clinique La louvère – Lille – France, Congeital heart disease explorations unit – UE3C Lowendal - Paris, Dijon University Hospital, Hospices Civils de Lyon, Marseille University Hospital, Martinique University Hospital, Nantes University Hospital, Private cardiology practice, Brest, Private cardiology practice, Marseille, Private cardiology practice, Massy, Private cardiology practice, Pontoise, Private cardiology practice, Rennes, Private cardiology practice, Strasbourg, Toulouse University Hospital, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Grenoble, University Hospital, Rouen, University Hospital, Tours |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis | Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis | 1 day | |
| Secondary | Rate of genetic anomaly with an isolated right aortic arch | 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 |
1 day | |
| Secondary | Rate of realization of chest CT angiography before the first year of life with an isolated right aortic arch | 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 |
1 day | |
| Secondary | Rate of surgical repair during the first year of life after prenatal diagnosis of an isolated right aortic arch. | If performing a surgery the first year of life: Indication: prophylactic or symptomatic Type of intervention Age at the intervention |
1 day | |
| Secondary | Rate of respiratory and digestive complications in the first year of life. | Functional signs of tracheal or esophageal compression in the first year of life. | 1 day |