Coronary Artery DiseasePREDICTNCT07822737
PCCT-Defined High-Risk Plaque and Future Coronary Events: The PREDICT Study
An observational study of Coronary Artery Disease and Plaque, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This prospective cohort study aims to determine whether high-risk coronary plaques identified by novel Photon-Counting Detector CT (PCCT) independently predict future major adverse cardiovascular events (MACE). Participants will be followed for MACE and revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Plaque, Photon-Counting Computed Tomography
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2025to 30 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Patient with coronary artery disease
Who may be able to join
- Age ≥18 years
- Scheduled for clinically indicated, non-emergent invasive coronary angiography
- Provision of written informed consent and willingness to comply with long-term follow-up
Who cannot join
- Estimated glomerular filtration rate <45 mL/min/1.73 m²
- Known allergy to iodinated contrast media
- Pregnancy or breastfeeding
- Persistent atrial fibrillation or other arrhythmia precluding adequate ECG-gated CT acquisition
- Body mass index >40 kg/m²
- Target vessel with a previously implanted stent
- Life expectancy <2 years or any condition that, in the opinion of the investigator, makes follow-up unlikely or participation inappropriate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital，Capital Medical University, Beijing
Beijing, China, 10000
Bin Tu, MD, PhD, +8618810682692, dr_bintu@163.com
About this study
Official title: Prognostic Value of Photon-Counting Detector CT-Derived High-Risk Coronary Plaque Features for Predicting Major Adverse Cardiovascular Events: a Prospective Cohort Study
This prospective cohort study aims to determine whether high-risk coronary plaques identified by novel Photon-Counting Detector CT (PCCT) independently predict future major adverse cardiovascular events (MACE). Participants will be followed for MACE and revascularization. The primary hypothesis is that the incidence of MACE is significantly higher in patients with PCCT-defined high-risk plaque than in those without. Additionally, patients will undergo Optical Coherence Tomography (OCT) and angiography within a month after PCCT; PCCT results will be compared with OCT in a cross-sectional analysis, and diagnostic performance will be evaluated against follow-up data.
Read the detailed description
Photon-Counting Detector CT (PCCT) enables improved spatial resolution and spectral tissue characterization, allowing non-invasive detection of high-risk coronary plaque (HRP) features such as low-attenuation plaque (<30 HU), positive remodeling (index ≥1.1), spotty calcification, and the napkin-ring sign. The presence of ≥2 of these features defines a PCCT-detected high-risk plaque. Optical Coherence Tomography (OCT), an invasive high-resolution imaging tool, defines HRP by thin-cap fibroatheroma (fibrous cap thickness <65 μm, lipid arc >90°) and other vulnerable features. While OCT provides detailed information on plaque vulnerability, it is invasive and limited to selected vessels. The prognostic significance of PCCT-defined HRP, and its diagnostic agreement with OCT, remain to be fully established.
This prospective, single-centre study will enroll patients with acute or stable coronary syndromes who are scheduled for clinically indicated invasive coronary angiography and OCT evaluation of at least one native coronary artery. All participants will first undergo a dedicated contrast-enhanced PCCT coronary angiogram. Within 30 days after PCCT, participants will undergo invasive coronary angiography with OCT imaging. Thus, OCT is systematically acquired after the CT, allowing a cross-sectional diagnostic comparison where PCCT findings are evaluated against the OCT reference. Both imaging datasets will be analyzed by independent core laboratories blinded to each other's results and to clinical data.
The study has two integrated components:
- Prognostic component - The primary objective is to assess whether the presence of PCCT-defined HRP independently predicts the 2-year incidence of MACE (cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina requiring urgent revascularization). The primary hypothesis is that MACE rate is significantly higher in patients with PCCT-HRP than in those without.
- Cross-sectional diagnostic comparison - Using OCT as the invasive reference, the diagnostic performance of PCCT for identifying high-risk plaque will be determined. Per-patient and per-lesion sensitivity, specificity, positive and negative predictive values, and overall accuracy of PCCT will be calculated and compared with OCT-derived high-risk plaque classification.
Participants will be followed prospectively for MACE and unplanned revascularization over 24 months.
- Keywords
- Photon-Counting Computed Tomography, Coronary Artery Disease, High risk plaque
- Medical subject headings
- Coronary Artery Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCCT High-Risk Plaque Group | Participants with PCCT-defined high-risk plaque in at least one native coronary artery. High-risk plaque is defined as the presence of ≥2 of the following features on PCCT: low-attenuation plaque (<30 Hounsfield Units), positive remodeling (remodeling index ≥1.1), spotty calcification (<3 mm), and the napkin-ring sign. | |
| PCCT Non-High-Risk Plaque Group | Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE)
Incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and hospitalization for unstable angina requiring urgent revascularization, stratified by the presence versus absence of PCCT-defined high-risk plaque.
Measured: Up to 24 months
Secondary outcomes (2)
Per-lesion MACE
Per-lesion hazard ratio of MACE for PCCT-defined HRP and OCT-defined HRP, adjusted for baseline clinical risk factors
Measured: Up to 24 months
Myocardial infarction
Time to first non-fatal myocardial infarction
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start18 Jan 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Zhao, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822737
- Sponsor's protocol ID
- 2025-ke-1040
- Acronym
- PREDICT
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Photon-Counting Detector CT-Derived High-Risk Coronary Plaque Features for Predicting Major Adverse Cardiovascular Events: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07822737
- Acronym / sponsor ID
- PREDICT / 2025-ke-1040
- Keywords
- Photon-Counting Computed Tomography, Coronary Artery Disease, High risk plaque
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 16 Sep 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 cohort study aims to determine whether high-risk coronary plaques identified by novel Photon-Counting Detector CT (PCCT) independently predict future major adverse cardiovascular events (MACE). Participants will be followed for MACE and revascularization. The primary hypothesis is that the incidence of MACE is significantly higher in patients with PCCT-defined high-risk plaque than in those without. Additionally, patients will undergo Optical Coherence Tomography (OCT) and angiography within a month after PCCT; PCCT results will be compared with OCT in a cross-sectional analysis, and diagnostic performance will be evaluated against follow-up data.
Detailed description
Photon-Counting Detector CT (PCCT) enables improved spatial resolution and spectral tissue characterization, allowing non-invasive detection of high-risk coronary plaque (HRP) features such as low-attenuation plaque (<30 HU), positive remodeling (index ≥1.1), spotty calcification, and the napkin-ring sign. The presence of ≥2 of these features defines a PCCT-detected high-risk plaque. Optical Coherence Tomography (OCT), an invasive high-resolution imaging tool, defines HRP by thin-cap fibroatheroma (fibrous cap thickness <65 μm, lipid arc >90°) and other vulnerable features. While OCT provides detailed information on plaque vulnerability, it is invasive and limited to selected vessels. The prognostic significance of PCCT-defined HRP, and its diagnostic agreement with OCT, remain to be fully established.
This prospective, single-centre study will enroll patients with acute or stable coronary syndromes who are scheduled for clinically indicated invasive coronary angiography and OCT evaluation of at least one native coronary artery. All participants will first undergo a dedicated contrast-enhanced PCCT coronary angiogram. Within 30 days after PCCT, participants will undergo invasive coronary angiography with OCT imaging. Thus, OCT is systematically acquired after the CT, allowing a cross-sectional diagnostic comparison where PCCT findings are evaluated against the OCT reference. Both imaging datasets will be analyzed by independent core laboratories blinded to each other's results and to clinical data.
The study has two integrated components:
- Prognostic component - The primary objective is to assess whether the presence of PCCT-defined HRP independently predicts the 2-year incidence of MACE (cardiovascular death, non-fatal myocardial infarction, hospitalization for unstable angina requiring urgent revascularization). The primary hypothesis is that MACE rate is significantly higher in patients with PCCT-HRP than in those without.
- Cross-sectional diagnostic comparison - Using OCT as the invasive reference, the diagnostic performance of PCCT for identifying high-risk plaque will be determined. Per-patient and per-lesion sensitivity, specificity, positive and negative predictive values, and overall accuracy of PCCT will be calculated and compared with OCT-derived high-risk plaque classification.
Participants will be followed prospectively for MACE and unplanned revascularization over 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCCT High-Risk Plaque Group | – | –Participants with PCCT-defined high-risk plaque in at least one native coronary artery. High-risk plaque is defined as the presence of ≥2 of the following features on PCCT: low-attenuation plaque (<30 Hounsfield Units), positive remodeling (remodeling index ≥1.1), spotty calcification (<3 mm), and the napkin-ring sign. |
| PCCT Non-High-Risk Plaque Group | – | –Participants without PCCT-defined high-risk plaque (0 or 1 high-risk feature) in any imaged coronary segment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with coronary artery disease
Key inclusion criteria (3 listed)
- Age ≥18 years
- Scheduled for clinically indicated, non-emergent invasive coronary angiography
- Provision of written informed consent and willingness to comply with long-term follow-up
Key exclusion criteria (7 listed)
- Estimated glomerular filtration rate <45 mL/min/1.73 m²
- Known allergy to iodinated contrast media
- Pregnancy or breastfeeding
- Persistent atrial fibrillation or other arrhythmia precluding adequate ECG-gated CT acquisition
- Body mass index >40 kg/m²
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
Incidence of major adverse cardiovascular events (MACE)
Time frame: Up to 24 months
Incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and hospitalization for unstable angina requiring urgent revascularization, stratified by the presence versus absence of PCCT-defined high-risk plaque.
2 secondary outcomes
Per-lesion MACE
Time frame: Up to 24 months
Myocardial infarction
Time frame: Up to 24 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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 Coronary Artery Disease and Plaque, run by Beijing Chao Yang Hospital at 1 site in China.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 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 China. 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?
Contact Bin Tu, MD.PhD (+8618810682692, dr_bintu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) (time frame: Up to 24 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 16 Sep 2026.