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

Centro Cardiologico Monzino

Status: Enrolling

Conditions: Chronic Coronary Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT06337461

CCM1930

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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