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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Policlinico San Donato
Coordinator of this site? Confirm its status
San Donato MilaneseItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.