Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with pre-natal or post-natal diagnosis of aortic coarctation from 01 January 2000 until approval (retrospective phase) and from approval until 31 December 2026 (prospective phase)

Disqualifiers

Patients whose diagnosis of aortic coarctation is postnatal, considered to be >1 month after birth

prenatal diagnosis of genetic disease (e.g., Turner's Sdr)

coarctation in the setting of complex congenital heart disease

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.