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

NCT05159791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-07

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • University of Pavia

    collaborator OTHER

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Mauro Lo Rito, MD · IRCCS Policlinico S. Donato

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159791 on ClinicalTrials.gov