Actively Recruiting
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-06
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are analyzing clinical and echocardiographic features of infants with prenatal or neonatal diagnosis of suspected aortic coarctation (CoAo). The study aims to identify signs that predict the risk of developing CoAo during the newborn period. This will help distinguish high-risk infants needing intensive care from those who may be safely discharged early. The study is observational and includes both retrospective and prospective data collection from 2000 to 2026. The study involves observing infants diagnosed with suspected or confirmed CoAo who are admitted to the Pediatric Cardiology and Cardiac Surgery Center at Policlinico di Sant'Orsola. No experimental treatments or interventions are applied; instead, researchers gather clinical data and echocardiographic results routinely collected during standard care. This approach allows the study of real-world clinical practice without altering patient management. Participants undergo routine clinical and echocardiographic evaluations. The research team collects and analyzes these data to identify predictive features of CoAo development over an average follow-up of five years. The study continues through December 2026, focusing on improving early identification of infants at risk for CoAo and informing care decisions.
CONDITIONS
Brief Title
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Patients whose diagnosis of aortic coarctation is postnatal, considered to be >1 month after birth
- Prenatal diagnosis of genetic disease (e.g., Turner's Syndrome)
- Coarctation in the setting of complex congenital heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years or until study completion
Participants who undergo routine care are observed, and clinical and echocardiographic data commonly collected by physicians in daily practice are recorded to identify features predictive of aortic coarctation.
Visits as per routine clinical practice
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
Y
Ylenia Bartolacelli, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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