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 :
Condition or disease |
---|
Isolated Right Aortic Arch |
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:
Echocardiographic data:
If performing a chest CT scan in the first year of life:
If performing an ante- or post-natal genetic sampling:
If performing a surgery during the first year of life:
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 |
Incidence of genetic anomaly with an isolated right aortic arch by specifying :
If performing a chest CT scan the first year of life:
If performing a surgery the first year of life:
Ages Eligible for Study: | up to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria:
• Prenatal diagnosis of an isolated right aortic arch
Exclusion criteria:
France | |
Uh Montpellier | |
Montpellier, France, 34295 |
Principal Investigator: | Sophie GUILLAUMONT, MD | University Hospital, Montpellier |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | April 25, 2019 | ||||
First Posted Date | July 23, 2019 | ||||
Last Update Posted Date | March 10, 2020 | ||||
Actual Study Start Date | April 1, 2019 | ||||
Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Management of Prenatally Diagnosed Isolated Right Aortic Arch | ||||
Official Title | Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study | ||||
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 :
|
||||
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:
Echocardiographic data:
If performing a chest CT scan in the first year of life:
If performing an ante- or post-natal genetic sampling:
If performing a surgery during the first year of life:
|
||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Children with antenatal diagnosis of isolated right aortic arch | ||||
Condition | Isolated Right Aortic Arch | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | December 31, 2019 | ||||
Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion criteria: • Prenatal diagnosis of an isolated right aortic arch Exclusion criteria:
|
||||
Sex/Gender |
|
||||
Ages | up to 1 Year (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04029064 | ||||
Other Study ID Numbers | RECHMPL19_0146 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor | University Hospital, Montpellier | ||||
Collaborators |
|
||||
Investigators |
|
||||
PRS Account | University Hospital, Montpellier | ||||
Verification Date | March 2019 |