Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).

On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography.

Disqualifiers

Low pre-test likelihood of CAD

Prior myocardial infarction

Previous history of revascularization

Acute coronary syndrome

Trial population

A total of 400 consecutive symptomatic patients with suspected CAD who were recruited for non-emergent, clinically indicated non-invasive coronary angiography with eventually dynamic stress computed tomography perfusion study

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Development of a computational model to predict MBF avoiding CT stress protocol

CONCERTO main aim is to predict MBF values from cardiac CT scans without stress protocol. This aim will be achieved by improving an existing computational model. To achieve this goal, we first need to explore available information on the effect of stenosis on the pressure gradient across it and the division of flow in the coronary tree. A second step will be a ML analysis on a reasonable number of patients with known myocardial perfusion (from CT-stress) to build a suitable neural network that can predict some general features of the model parameters. This neural network will allow us to include this information in our calibration procedure and use also it for future patients in whom stress CT will no longer be necessary. Finally, a comprehensive, patient-specific model calibration strategy will be developed leveraging the results. This will allow us to apply our tool to any patient as long as a standard CT acquisition and some pressure

Time frame
May 2025

Secondary outcomes

1

Improvement of CAD risk assesment

The second Aim is to improve CAD risk assessment by integrating the information from the perfusion computation model with imaging and radiomics features

Time frame
May 2025

Other outcomes

Sponsors and contacts

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Centro Cardiologico Monzino

Lead sponsor

Politecnico di Milano

Collaborator

University of Bari

Collaborator