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Clinical Trials in Italy / NCT06759103
Recruiting Observational

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

NCT06759103 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2021-03-01
Last updated
2025-01-06

Condition(s) studied

Aortic Coarctation

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * 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

Primary outcome measure(s)

  • Identify clinical or echocardiographic features, predictive of development of aortic coarctation — Through study completion, an average of 5 years
    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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759103 on ClinicalTrials.gov ↗ ← All trials in Italy