Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT06759103
Status:
RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACOAP
Brief Summary:
The purpose of this prosective and retrospective observational study is to analyze the clinical and echocardiographic characteristics of infants with prenatal diagnosis of suspected aortic coarctation (CoAo) in order to identify clinical and instrumental elements that can predict the risk of developing aortic coarctation in the neonatal period so that we can identify patients who are at high risk and would therefore require intensive care and observation; compared with low-risk patients, for whom early discharge would be evaluable.
Detailed Description:
Our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected CoAo, transferred at birth to the O.U. of Cardiology and Paediatric Cardiac Surgery at the Policlinico di Sant' Orsola in order to identify reliable predictors of CoAo, in particular reliable in presence of the ductus arteriosus of Botallo.
It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is:
to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.
It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is:
to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: