Analyzing characteristics of infants with suspected aortic coarctation
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06759103
This study looks at the health details of infants suspected to have aortic coarctation to see if it can help identify which babies need extra care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06759103 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the clinical and echocardiographic characteristics of infants diagnosed with suspected aortic coarctation, both prenatally and postnatally. By collecting data from patients admitted to the Pediatric Cardiology and Cardiac Surgery Center at Policlinico di Sant'Orsola, the study seeks to identify predictors of aortic coarctation that can inform the level of care required for these infants. The study will utilize existing clinical practices and data without introducing any new interventions, focusing on the identification of high-risk patients who may need intensive monitoring. The data collection will span from January 2007 to December 2026.
Who should consider this trial
Good fit: Ideal candidates include infants with prenatal or postnatal diagnoses of aortic coarctation from January 2000 onwards.
Not a fit: Patients diagnosed with aortic coarctation more than one month after birth or those with complex congenital heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of infants at high risk for aortic coarctation, allowing for timely interventions and better management.
How similar studies have performed: While this approach is observational and builds on existing clinical practices, similar studies have shown promise in identifying risk factors for congenital heart conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Ylenia Bartolacelli, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Ylenia Bartolacelli, MD
- Email: ylenia.bartolacelli@aosp.bo.it
- Phone: 0512149072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Coarctation