New Patient-specific Functional Assessment of the Anomalous Aortic Origin of Coronary Arteries.

NCT ID: NCT05159791

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2024-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Anomalous coronary blood flow

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).

Group Type: EXPERIMENTAL

Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation

Intervention Type: DIAGNOSTIC_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.

Interventions

Invasive coronary blood flow assessment and simulations and fluid dynamic patient specific simulation

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: collaborator

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Mauro Lo Rito

Pediatric Cardiac Surgeon and Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro Lo Rito, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Donato

Locations

Irccs Policlinico San Donato

San Donato Milanese, MI, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37838795 (View on PubMed)

Other Identifiers

GR-2019-12369116

Identifier Type: -

Identifier Source: org_study_id