Aortic CoarctationACOAPNCT06759103
Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
An observational study of Aortic Coarctation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Coarctation
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Ylenia Bartolacelli, MD, 0512149072, ylenia.bartolacelli@aosp.bo.it
About this study
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.
Read the detailed description
Our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected CoAo, transferred at birth to the O.U. of Cardiology and Paediatric Cardiac Surgery at the Policlinico di Sant' Orsola in order to identify reliable predictors of CoAo, in particular reliable in presence of the ductus arteriosus of Botallo.
It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is:
to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.
- Conditions
- Aortic Coarctation
- Medical subject headings
- Aortic Coarctation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Mar 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ylenia Bartolacelli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759103
- Sponsor's protocol ID
- ACOAP
- Acronym
- ACOAP
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Archive of Patients With Diagnosis and Suspected Prenatal Diagnosis of Aortic Coarctation
- ClinicalTrials.gov ID
- NCT06759103
- Acronym / sponsor ID
- ACOAP / ACOAP
- Conditions
- Aortic Coarctation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected CoAo, transferred at birth to the O.U. of Cardiology and Paediatric Cardiac Surgery at the Policlinico di Sant' Orsola in order to identify reliable predictors of CoAo, in particular reliable in presence of the ductus arteriosus of Botallo.
It is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. This study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.The primary objective of the study is:
to identify the clinical and/or echocardiographic features predictive of the development of Aortic Coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt Aortic Coarctation, admitted from 01/01/2007 to 31/12/2026 at the Paediatric Cardiology and Cardiac Surgery Centre of the Policlinico di Sant'Orsola, Bologna.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify clinical or echocardiographic features, predictive of development of aortic coarctation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Morality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ylenia Bartolacelli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coarctation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ylenia Bartolacelli, MD (0512149072, ylenia.bartolacelli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify clinical or echocardiographic features, predictive of development of aortic coarctation (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.