Clinical trial NCT05159791: New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
Official title: New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
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
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2021-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Identification of myocardial ischemia on simulation model
timeFrame: 3 years
Secondary outcomes:
measure: Invasive coronary flow distribution assessment
timeFrame: During clinical diagnostic evaluation, average 3 months after
measure: Integration of different coronary artery imaging modality
timeFrame: During clinical diagnostic evaluation, average 6 months
measure: Computational fluid dynamic simulation
timeFrame: 3 years
measure: In vitro effort fluid dynamic simulation
timeFrame: 3 years
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: Irccs Policlinico San Donato
state: MI
Study officials:
affiliation: IRCCS Policlinico S. Donato
name: Mauro Lo Rito, MD
role: PRINCIPAL_INVESTIGATOR
References: