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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndrome

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Gianluca Pontone, MD; Phone Number: +39 0258002574; Email: gianluca.pontone@cardiologicomonzino.it

Study Locations

• Italy
  • Milan, Italy, 20131
    • Recruiting
    • Centro Cardiologico Monzino
    • Contact: Chiara Centenaro; Phone Number: +39 0258002031; Email: chiara.centenaro@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Low pre-test likelihood of CAD
• Prior myocardial infarction
• Previous history of revascularization
• Acute coronary syndrome
• Need for an emergent procedure
• Evidence of clinical instability
• Contraindication for contrast agent or impaired renal function
• Inability to sustain a breath-hold
• Pregnancy
• Atrial fibrillation or flutter
• BMI > 35kg/m2
• Presence of pm or ICD
• Contraindications to the administration of sublingual nitrates, betablockade, and adenosine

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Building the neural network from the measured blood flow maps will allow us to include this information in our calibration procedure and also use 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	May 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	May 2025

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Politecnico di Milano; Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Myocardial Blood Flow; CT Perfusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Stenosis; Plaque, Atherosclerotic
• Other Study ID Numbers: CCM1930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No