Chronic Coronary SyndromeCONCERTONCT06337461
Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography
An observational study of Chronic Coronary Syndrome, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2023to 19 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Coronary Syndrome
- Keywords
- CT Perfusion, Myocardial Blood Flow
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start22 May 2023
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, University of Bari
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337461
- Sponsor's protocol ID
- CCM1930
- Acronym
- CONCERTO
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography
- ClinicalTrials.gov ID
- NCT06337461
- Acronym / sponsor ID
- CONCERTO / CCM1930
- Conditions
- Chronic Coronary Syndrome
- Keywords
- CT Perfusion, Myocardial Blood Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Politecnico di Milano, University of Bari
- Study start
- 22 May 2023 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography.
Key exclusion criteria (13 listed)
- Low pre-test likelihood of CAD
- Prior myocardial infarction
- Previous history of revascularization
- Acute coronary syndrome
- Need for an emergent procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a computational model to predict MBF avoiding CT stress protocol
Time frame: May 2025
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
1 secondary outcome
Improvement of CAD risk assesment
Time frame: May 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a computational model to predict MBF avoiding CT stress protocol (time frame: May 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.