CAD - Coronary Artery DiseaseEXIT-CVDNCT07857031
EXIT-CVD Project: Evidence Based Exit Strategies for the Cardiovascular Disease Continuum Trough Early Detection, Treatment and Evaluation
A study testing Photon Counting Computed Tomography (PCCT) in people with CAD - Coronary Artery Disease, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
This prospective, single-center interventional imaging study aims to evaluate the diagnostic performance of Photon Counting Computed Tomography (PCCT) combined with artificial intelligence-based Quantitative Coronary CT (AI-QCT) analysis in patients with suspected or known coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease
- What is being tested?
- Photon Counting Computed Tomography (PCCT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults (≥ 18 years)
- Patients with suspected or known CAD and a positive conventional coronary CT angiography requiring further invasive evaluation.
- Patients scheduled for clinically indicated invasive coronary angiography with IVUS assessment.
- Ability to under go an additional PCCT scan according to the study protocol
- Ability and willingness to provide written informed consent.
Who cannot join
- Contraindications to CT imaging or iodinated contrast media
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Pregnancy or breastfeeding.
- Hemodynamic instability or inability to undergo CT acquisition
- Significant arrhythmias impairing image acquisition quality.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXIT-CVD Project: Evidence Based Exit Strategies for the Cardiovascular Disease Continuum Trough Early Detection, Treatment and Evaluation (EXIT-CVD)
This prospective, single-center interventional imaging study aims to evaluate the diagnostic performance of Photon Counting Computed Tomography (PCCT) combined with artificial intelligence-based Quantitative Coronary CT (AI-QCT) analysis in patients with suspected or known coronary artery disease (CAD).
Read the detailed description
Adult patients with a positive conventional coronary CT angiography (CCTA) who are scheduled for clinically indicated invasive coronary angiography with intravascular ultrasound (IVUS) will undergo an additional PCCT acquisition for research purposes. PCCT datasets will be analyzed using a dedicated post-processing platform implementing artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for automated plaque quantification and characterization, including assessment of plaque burden, plaque composition, stenosis severity, and high risk plaque features. Conventional CCTA and PCCT images will be compared within the same patient to assess image quality, coronary stenosis, plaque burden and composition, high-risk plaque features, CAD-RADS classification, radiation exposure, and contrast medium volume.
Invasive coronary angiography and IVUS findings will serve as reference standards to evaluate the diagnostic accuracy and agreement of CT-derived measurements. The study will assess whether PCCT combined with AI-QCT provides improved coronary plaque characterization, diagnostic performance, and cardiovascular risk stratification compared with conventional CCTA, while potentially reducing radiation exposure and contrast medium requirements.
- Conditions
- CAD - Coronary Artery Disease
- Being tested
- Photon Counting Computed Tomography (PCCT)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Counting Computed Tomography (PCCT)Radiation
Participants will undergo an additional Photon Counting Computed Tomography (PCCT) coronary angiography acquisition for research purposes after a clinically performed conventional coronary CT angiography. The PCCT examination will be performed using an optimized low-dose acquisition protocol. PCCT images will be analyzed using a dedicated image post-processing platform incorporating artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for quantitative and qualitative assessment of coronary artery disease, including coronary stenosis, plaque burden, plaque composition, and high-risk plaque features. Image quality, radiation exposure, and contrast medium volume will also be assessed.
| Study group | Role | What they receive |
|---|---|---|
| PCCT and AI-QCT Imaging | Experimental | Participants with suspected or known coronary artery disease and a positive conventional coronary CT angiography (CCTA) will undergo an additional Photon Counting Computed Tomography (PCCT) acquisition for research purposes. PCCT images will be analyzed using a dedicated image post-processing platform incorporating artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for the assessment of coronary stenosis, plaque burden, plaque composition, and high-risk plaque features. PCCT findings will be compared with conventional CCTA findings and with invasive coronary angiography and intravascular ultrasound (IVUS), which will serve as reference standards. Receives: Radiation: Photon Counting Computed Tomography (PCCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of PCCT combined with AI-QCT compared with conventional CCTA
Diagnostic performance of PCCT combined with AI-QCT for the detection and assessment of coronary artery disease, compared with conventional CCTA.
Measured: 16 months
Secondary outcomes (7)
Signal-to-noise ratio (SNR)
Signal-to-noise ratio measured on conventional CCTA and PCCT images
Measured: 16 months
Quantitative and qualitative coronary plaque characteristics measured by AI-QCT
Plaque burden, plaque composition, and high-risk plaque features measured by AI-QCT on conventional CCTA and PCCT images.
Measured: 16 months
Radiation dose associated with conventional CCTA and PCCT
Radiation dose recorded for conventional CCTA and PCCT acquisitions.
Measured: 16 months
CAD-RADS classification
CAD-RADS classification assigned to conventional CCTA and PCCT datasets.
Measured: 16 months
Agreement between AI-QCT and IVUS measurements of coronary plaque
Agreement between non-invasive AI-QCT-derived measurements and corresponding invasive IVUS measurements of coronary plaque, assessed using intraclass correlation coefficient (ICC).
Measured: 16 months
Incremental value of PCCT for cardiovascular risk stratification
Evaluation of the incremental value of PCCT combined with AI-QCT compared with conventional CCTA for cardiovascular risk stratification and clinical decision making.
Measured: 16 months
Contrast-to-noise ratio (CNR)
Contrast-to-noise ratio measured on conventional CCTA and PCCT images.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857031
- Sponsor's protocol ID
- L2-703
- Acronym
- EXIT-CVD
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXIT-CVD Project: Evidence Based Exit Strategies for the Cardiovascular Disease Continuum Trough Early Detection, Treatment and Evaluation (EXIT-CVD)
- ClinicalTrials.gov ID
- NCT07857031
- Acronym / sponsor ID
- EXIT-CVD / L2-703
- Conditions
- CAD - Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Oct 2026 (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.
This prospective, single-center interventional imaging study aims to evaluate the diagnostic performance of Photon Counting Computed Tomography (PCCT) combined with artificial intelligence-based Quantitative Coronary CT (AI-QCT) analysis in patients with suspected or known coronary artery disease (CAD).
Detailed description
Adult patients with a positive conventional coronary CT angiography (CCTA) who are scheduled for clinically indicated invasive coronary angiography with intravascular ultrasound (IVUS) will undergo an additional PCCT acquisition for research purposes. PCCT datasets will be analyzed using a dedicated post-processing platform implementing artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for automated plaque quantification and characterization, including assessment of plaque burden, plaque composition, stenosis severity, and high risk plaque features. Conventional CCTA and PCCT images will be compared within the same patient to assess image quality, coronary stenosis, plaque burden and composition, high-risk plaque features, CAD-RADS classification, radiation exposure, and contrast medium volume.
Invasive coronary angiography and IVUS findings will serve as reference standards to evaluate the diagnostic accuracy and agreement of CT-derived measurements. The study will assess whether PCCT combined with AI-QCT provides improved coronary plaque characterization, diagnostic performance, and cardiovascular risk stratification compared with conventional CCTA, while potentially reducing radiation exposure and contrast medium requirements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCCT and AI-QCT Imaging | Experimental | Radiation: Photon Counting Computed Tomography (PCCT)Participants with suspected or known coronary artery disease and a positive conventional coronary CT angiography (CCTA) will undergo an additional Photon Counting Computed Tomography (PCCT) acquisition for research purposes. PCCT images will be analyzed using a dedicated image post-processing platform incorporating artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for the assessment of coronary stenosis, plaque burden, plaque composition, and high-risk plaque features. PCCT findings will be compared with conventional CCTA findings and with invasive coronary angiography and intravascular ultrasound (IVUS), which will serve as reference standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥ 18 years)
- Patients with suspected or known CAD and a positive conventional coronary CT angiography requiring further invasive evaluation.
- Patients scheduled for clinically indicated invasive coronary angiography with IVUS assessment.
- Ability to under go an additional PCCT scan according to the study protocol
- Ability and willingness to provide written informed consent.
Key exclusion criteria (6 listed)
- Contraindications to CT imaging or iodinated contrast media
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- Pregnancy or breastfeeding.
- Hemodynamic instability or inability to undergo CT acquisition
- Significant arrhythmias impairing image acquisition quality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon Counting Computed Tomography (PCCT)Participants will undergo an additional Photon Counting Computed Tomography (PCCT) coronary angiography acquisition for research purposes after a clinically performed conventional coronary CT angiography. The PCCT examination will be performed using an optimized low-dose acquisition protocol. PCCT images will be analyzed using a dedicated image post-processing platform incorporating artificial intelligence-based Quantitative Coronary CT (AI-QCT) algorithms for quantitative and qualitative assessment of coronary artery disease, including coronary stenosis, plaque burden, plaque composition, and high-risk plaque features. Image quality, radiation exposure, and contrast medium volume will also be assessed. | Radiation | PCCT and AI-QCT Imaging |
Primary outcome
Diagnostic performance of PCCT combined with AI-QCT compared with conventional CCTA
Time frame: 16 months
Diagnostic performance of PCCT combined with AI-QCT for the detection and assessment of coronary artery disease, compared with conventional CCTA.
7 secondary outcomes
Signal-to-noise ratio (SNR)
Time frame: 16 months
Quantitative and qualitative coronary plaque characteristics measured by AI-QCT
Time frame: 16 months
Radiation dose associated with conventional CCTA and PCCT
Time frame: 16 months
CAD-RADS classification
Time frame: 16 months
Agreement between AI-QCT and IVUS measurements of coronary plaque
Time frame: 16 months
Incremental value of PCCT for cardiovascular risk stratification
Time frame: 16 months
Contrast-to-noise ratio (CNR)
Time frame: 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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?
A study testing Photon Counting Computed Tomography (PCCT) in people with CAD - Coronary Artery Disease, 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic performance of PCCT combined with AI-QCT compared with conventional CCTA (time frame: 16 months). 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 5 Oct 2026.