An observational study in Aortic Coarctation, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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All patients with suspected prenatal diagnosis of aortic coarctation, referred to our next center from 01 January 2000 to 31 December 2026 will be considered going to include, according to a preliminary analysis, a cohort of about 150 patients.
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Exclusion Criteria:
Identify clinical or echocardiographic features, predictive of development of aortic coarctation
The study is observational, non-interventional in nature. Patients will be treated according to clinical practice. In particular, information will be collected regarding: * ECG * Transthoracic echocardiogram * Interventional or surgical procedures * Follow-up examinations The diagnosis of isthmic aortic coarctation is based on the echocardiographic finding. Clinically, coarctation is defined as significant and with indication for surgical correction in the presence of signs of reduced abdominal systemic perfusion.
Time frame: Through study completion, an average of 5 years
Plan to share: No
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