NCT05159791Completed
New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
Anomalous Aortic Origin of the Coronary Arteries (AAOCA) is a rare congenital disease that may cause sudden death in young subjects. Frequently the first and only presentation is with an acute event (such as myocardial infarction or sudden cardiac deaths) during physical effort. Not only symptoms are often absent, but also provocative tests fail to induce ischemia or related signs, showing in most patients negative results. For these limitations, the decision to undergo corrective surgery is based on the morphologic characteristics without the support of a functional evaluation. The study focused on developing a personalized ischemic risk assessment with the aid of fluid dynamic simulations. The simulation system integrate clinical data from different diagnostic sources and integrate them with coronary blood flow evaluation at rest and during simulated physical effort.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 16 Nov 2021
- Start date
- 23 Nov 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- IRCCS Policlinico S. Donato
- Diseases
- Coronary artery disease
- NCT number
- NCT05159791
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 23 Nov 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A presence of major associated congenital heart anomalies
Age
- Contraindication to the execution of the diagnostic examination requested such as age \< 14 years for invasive coronary flow measurements
Who the study is looking for
- Patients with a diagnosis of AAOCA of any age will undergo fluid dynamic simulation
- Patients with age \> 14 with diagnosis of AAOCA will undergo to invasive coronary flow measurements
- Informed consent
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.