Anomalous Coronary Artery OriginNECESSARYNCT05159791
New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
A study testing Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation in people with Anomalous Coronary Artery Origin and Anomalous Coronary Artery Arising from the Opposite Sinus, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Anomalous Coronary Artery Origin, Anomalous Coronary Artery Arising from the Opposite Sinus, Anomalous Coronary Artery Course
- What is being tested?
- Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2021to 31 Dec 2024
- Phase
- Interventional
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A presence of major associated congenital heart anomalies
- Contraindication to the execution of the diagnostic examination requested such as age < 14 years for invasive coronary flow measurements
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Anomalous Aortic Origin of Coronary Arteries (AAOCA) is a congenital condition where one or more coronary vessels originate from an ectopic site within the aorta, such as the opposite or wrong sinus of Valsalva. Its prevalence in the general population, has been estimated between 0.03% and 0.23% depending on the variant evaluated. The anomalous left or right coronary artery, besides its origin, may take 5 different general courses: interarterial, prepulmonic, subpulmonic, retroaortic or retrocardiac. Each of these forms may be subject to cause myocardial ischemia and subsequent sudden death during physical and sport activity.
In most cases, the disease is silent and does not show any symptoms before the sudden cardiac death event (SCD). Only a few AAOCA subjects report symptoms before SCD that usually occurs unexpectedly after a moderate or intense physical activity. It is extremely hard to study the causing factors in a clinical environment due to the stochastic nature of the myocardial ischemic event and the inability to reproduce the exact effort conditions.
Even when a complete assessment is performed, there is no clinical exam that can reproduce sustained exercise conditions responsible for triggering ischemia and SCD. Even if such an exam would exist and provide adequate results, the risk of SCD exceeds the benefits of having a correct diagnosis.
To overcome all the current diagnostic limitations the ideal diagnostic test has to investigate coronary blood supply, myocardial oxygen demand in relation to the physical activity (intensity and duration) required for triggering an ischemic event, without putting the subjects at risk. To date the only possible way to reproduce such conditions is a subject-specific virtual simulation of aortic root and coronary artery integrated with coronary blood flow simulation able to mimic pressure, flow, and oxygen demand characteristics similar to those of intense exercise, in relation to changes that anomalous coronary undergoes under such conditions.
- Conditions
- Anomalous Coronary Artery Origin, Anomalous Coronary Artery Arising from the Opposite Sinus, Anomalous Coronary Artery Course, Anomalous Coronary Artery with Aortic Origin and Course Between the Great Arteries, Sudden Cardiac Death, Myocardial Ischemia
- Being tested
- Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation
- Keywords
- Fluid mechanics studies of circulation, Fluid mechanics studies of microcirculation, Fluid mechanics studies of transport systems, Biomechanics, Computational fluid dynamics, Hemodynamics, Mathematical modeling, Simulation, Ventricular remodeling, Tissue and organ mechanics, Mechanics of injury, Coronary congenital anomalies, Coronary blood flow assessment, Personalized functional risk assessment, Computaional fluid dynamics, Structural finite element analysis, Integration of multimodal imaging
- Medical subject headings
- Death, Sudden, Cardiac, Myocardial Ischemia, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulationDiagnostic test
The coronary blood flow and its distribution between the anomalous and normal artery will be measured by invasive coronary catheterization. Coronary artery flow will be calculated based on intravascular ultrasound (IVUS) and pressure difference measurements. After the IVUS assessment, a pressure transducer (FFR/iFR probe) will be inserted in the coronary artery for pressure measurements. The measurements will be done in the anomalous and normal coronary arteries in each patient to determine coronary flow distribution. Patient's specific heart parameters will be retrieve from CT, MRI and other diagnostic tests and integrated in the simulation module.
| Study group | Role | What they receive |
|---|---|---|
| Anomalous coronary blood flow | Experimental | Subjects suspected to have AAOCA will be submitted to angiographic coronary CT imaging to confirm the diagnosis. If the diagnosis of AAOCA will be confirmed, subjects will undergo to invasive coronary blood flow evaluation (intervention). Receives: Diagnostic Test: Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of myocardial ischemia on simulation model
Assess myocardial ischemia in the patient's specific model during simulated effort correlating coronary artery blood supply to myocardial oxygen demand.
Measured: 3 years
Secondary outcomes (4)
Invasive coronary flow distribution assessment
Evaluation of coronary blood flow (ml/min) in anomalous coronary artery and in normal coronary artery.
Measured: During clinical diagnostic evaluation, average 3 months after
Integration of different coronary artery imaging modality
CT 3D reconstruction of aorta and coronary artery with aorta and coronary artery cross-sectional area (mm2); IVUS coronary artery reconstruction cross-sectional area (mm2); coronary blood flow quantification (ml/min)
Measured: During clinical diagnostic evaluation, average 6 months
Computational fluid dynamic simulation
Correlation between at rest estimated coronary blood flow (patient's specific FSI model) and the measured invasive coronary blood flow (FFR and derived measures).
Measured: 3 years
In vitro effort fluid dynamic simulation
FSI model effort will be simulated by increasing heart rate (bpm) and pressure (mmHg) that will determine changes in coronary artery cross-sectional area (mm2). The outcome of the FSI effort simulation will be measured as changes in coronary artery blood flow (ml/min)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start23 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anomalous Coronary Artery OriginStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Mauro Lo Rito, IRCCS Policlinico S. Donato
- Investigators
- Mauro Lo Rito, MD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159791
- Sponsor's protocol ID
- GR-2019-12369116
- Acronym
- NECESSARY
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceserani V, Lo Rito M, Agnifili ML, Pascaner AF, Rosato A, Anglese S, Deamici M, Negri J, Corrado C, Bedogni F, Secchi F, Lombardi M, Auricchio F, Frigiola A, Conti M. Lumped-parameter model as a non-invasive tool to assess coronary blood flow in AAOCA patients. Sci Rep. 2023 Oct 14;13(1):17448. doi: 10.1038/s41598-023-44568-8.
PubMed 37838795