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

NCT ID: NCT06337461

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-22

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Politecnico di Milano

OTHER

Sponsor Role collaborator

University of Bari

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Cardiologico Monzino

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gianluca Pontone, MD

Role: CONTACT

0258002574 ext. +39

Facility Contacts

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Chiara Centenaro

Role: primary

0258002031 ext. +39

Other Identifiers

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CCM1930

Identifier Type: -

Identifier Source: org_study_id

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