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

NCT05159791 | Completed DMC

• 1 other identifier: GR-2019-12369116
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (4)

• Invasive coronary flow distribution assessment

  During clinical diagnostic evaluation, average 3 months after

• Integration of different coronary artery imaging modality

  During clinical diagnostic evaluation, average 6 months

• Computational fluid dynamic simulation

  3 years

• In vitro effort fluid dynamic simulation

  3 years

Study Arms (1)

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).

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

Interventions

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

Anomalous coronary blood flow

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• University of Pavia: collaborator

Study Sites (1)

Irccs Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (1)

• 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.

  PMID: 37838795 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Myocardial Ischemia; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Pathological Conditions, Anatomical

Study Officials

• Mauro Lo Rito, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiac Surgeon and Research Associate

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 16, 2021
• Study Start: November 23, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)