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

NCT06759103 | Recruiting

• 1 other identifier: ACOAP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Coarctation

Outcome Measures

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.

  Through study completion, an average of 5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ylenia Bartolacelli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ylenia Bartolacelli, MD

CONTACT

0512149072; ylenia.bartolacelli@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: March 1, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)