Coronary Artery DiseaseAI-CT-PLAQUENCT07886996
AI-Based CT Analysis of Coronary Plaque Evolution
An observational study of Coronary Artery Disease, run by Zhejiang Hospital at 5 sites in China.
Trial summary
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 326 participants
- Where
- 5 sitesChina
- Study dates
- Oct 2026to 31 Dec 2028
- 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: Adults with coronary plaque identified from existing clinical records and serial CCTA examinations at participating hospitals. The study uses retrospective, de-identified data and does not require additional examinations, interventions, or costs for participants.
Who may be able to join
- Adults aged 18 years or older.
- Baseline CCTA demonstrates coronary plaque in the LAD, LCX, RCA, or a major branch with reference diameter >=2.0 mm.
- No prior percutaneous coronary intervention or coronary artery bypass grafting.
- Baseline CCTA and at least one follow-up CCTA are available, with an interval of at least 6 months, preferably 12-36 months.
- Target segments can be longitudinally matched and non-calcified plaque volume and total vessel volume can be quantified.
- Image quality meets the core laboratory requirements.
Who cannot join
- Severe comorbid disease, active malignancy, acute or chronic inflammation, connective tissue or autoimmune disease, or life expectancy less than 1 year.
- Pregnancy.
- Prior PCI stent implantation or CABG.
- In-stent lesions, complete occlusion, thrombus, left main or ostial lesions, or other lesions preventing the planned hemodynamic or biomechanical analyses.
- Image quality or key data judged inadequate by the core laboratory.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Lin Yang, +86 571 87236114, zyct79@163.com
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310015
Peng Dong, +86 571 88303699, office@hz2-hospital.com
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Wenbin Zhang, +86 571 86090073, srrshts@sina.com
The Second People's Hospital of Yuhuan City
Yuhuan, Zhejiang, 317100
Qidong Zheng, +86 576 81748111, yuzqd@126.com
Zhoushan Hospital, Zhejiang Province
Zhoushan, Zhejiang, 316000
Bo Fang, +86 580 2558299, 260917687@qq.com
About this study
Official title: Artificial Intelligence-Based CT Analysis of Coronary Plaque Characteristics and Longitudinal Evolution
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque. Adults with coronary plaque on baseline coronary CT angiography (CCTA) and at least one follow-up CCTA obtained between January 1, 2020 and December 31, 2025 will be identified from participating centers. The system will integrate clinical factors, CCTA plaque morphology and burden, functional measures, hemodynamic parameters, and biomechanical features using baseline data. Two independent readers will assess conventional CCTA findings, including CAD-RADS and adverse plaque characteristics, while remaining blinded to system outputs. The primary outcome is patient-level definite progression of non-calcified plaque, defined by annualized change in non-calcified plaque percent atheroma volume exceeding the reproducibility-based minimum detectable change (MDC95). Model discrimination will be assessed by area under the receiver operating characteristic curve and compared with conventional CCTA models. Approximately 326 participants are planned.
Read the detailed description
The study uses existing de-identified clinical, laboratory, and serial CCTA data. Eligible participants are adults with coronary plaque, no prior percutaneous coronary intervention or coronary artery bypass grafting, baseline and follow-up CCTA separated by at least 6 months (preferably 12 to 36 months), longitudinally matchable target segments, and adequate image quality. The baseline CCTA will be used for model prediction; the follow-up CCTA will be used for outcome ascertainment. The primary endpoint is definite patient-level non-calcified plaque progression versus non-progression. Annualized change in non-calcified plaque percent atheroma volume will be compared with an MDC95 determined in a 30-50 participant repeatability substudy. Definite progression is greater than +MDC95, stability is within +/- MDC95, and definite reduction/regression is less than -MDC95. Secondary analyses will evaluate prediction of definite plaque reduction/regression, sensitivity, specificity, positive and negative predictive values, F1 score, calibration, Brier score, decision-curve analysis, and plaque-level analyses using generalized estimating equations or mixed-effects models to account for clustering within participants. Analyses will include patient-level cross-validation, center-level validation where feasible, subgroup analyses, and prespecified sensitivity analyses by follow-up interval, scanner/reconstruction protocol, and image quality. Data will be de-identified, encrypted, access-controlled, and analyzed without additional participant procedures or costs.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary plaque, coronary CT angiography, artificial intelligence, non-calcified plaque, plaque progression
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Plaque Cohort | Adults with coronary plaque identified on baseline CCTA and at least one follow-up CCTA. This observational cohort is analyzed using de-identified clinical and imaging data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-level definite non-calcified plaque progression discrimination (AUC)
Area under the receiver operating characteristic curve (AUC) with 95% confidence interval for the full-system model predicting definite patient-level progression of non-calcified plaque. Definite progression is annualized change in non-calcified plaque percent atheroma volume greater than +MDC95; non-progression includes stability and definite reduction/regression. AUC will be compared with conventional CCTA models using the DeLong test.
Measured: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Secondary outcomes (3)
Prediction of definite non-calcified plaque reduction/regression (AUC and classification metrics)
AUC with 95% confidence interval for predicting definite plaque reduction/regression, with sensitivity, specificity, positive predictive value, negative predictive value, and F1 score.
Measured: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Model calibration (Brier score)
The prespecified quantitative outcome is the Brier score for the full-system and conventional CCTA models, with calibration curves and the Hosmer-Lemeshow test reported as supporting calibration assessments. Prespecified subgroup and sensitivity analyses will assess robustness.
Measured: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Clinical net benefit (decision-curve analysis)
Clinical net benefit of the full-system and conventional CCTA models will be evaluated using decision-curve analysis across prespecified risk-threshold probabilities. Results will be reported as net benefit at each threshold; prespecified subgroup and sensitivity analyses will assess robustness.
Measured: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886996
- Sponsor's protocol ID
- ZJHIRB-2026-011K
- Acronym
- AI-CT-PLAQUE
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Symons R, Morris JZ, Wu CO, Pourmorteza A, Ahlman MA, Lima JA, Chen MY, Mallek M, Sandfort V, Bluemke DA. Coronary CT Angiography: Variability of CT Scanners and Readers in Measurement of Plaque Volume. Radiology. 2016 Dec;281(3):737-748. doi: 10.1148/radiol.2016161670. Epub 2016 Sep 16.
PubMed 27636027Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. doi: 10.1519/15184.1.
PubMed 15705040Won KB, Lee BK, Park HB, Heo R, Lee SE, Rizvi A, Lin FY, Kumar A, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Raff GL, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Quantitative assessment of coronary plaque volume change related to triglyceride glucose index: The Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry. Cardiovasc Diabetol. 2020 Jul 18;19(1):113. doi: 10.1186/s12933-020-01081-w.
PubMed 32682451Han D, Berman DS, Miller RJH, Andreini D, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Conte E, Marques H, de Araujo Goncalves P, Gottlieb I, Hadamitzky M, Leipsic J, Maffei E, Pontone G, Shin S, Kim YJ, Lee BK, Chun EJ, Sung JM, Lee SE, Virmani R, Samady H, Stone P, Narula J, Bax JJ, Shaw LJ, Lin FY, Min JK, Chang HJ. Association of Cardiovascular Disease Risk Factor Burden With Progression of Coronary Atherosclerosis Assessed by Serial Coronary Computed Tomographic Angiography. JAMA Netw Open. 2020 Jul 1;3(7):e2011444. doi: 10.1001/jamanetworkopen.2020.11444.
PubMed 32706382
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based CT Analysis of Coronary Plaque Characteristics and Longitudinal Evolution
- ClinicalTrials.gov ID
- NCT07886996
- Acronym / sponsor ID
- AI-CT-PLAQUE / ZJHIRB-2026-011K
- Conditions
- Coronary Artery Disease
- Keywords
- coronary plaque, coronary CT angiography, artificial intelligence, non-calcified plaque, plaque progression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 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 retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque. Adults with coronary plaque on baseline coronary CT angiography (CCTA) and at least one follow-up CCTA obtained between January 1, 2020 and December 31, 2025 will be identified from participating centers. The system will integrate clinical factors, CCTA plaque morphology and burden, functional measures, hemodynamic parameters, and biomechanical features using baseline data. Two independent readers will assess conventional CCTA findings, including CAD-RADS and adverse plaque characteristics, while remaining blinded to system outputs. The primary outcome is patient-level definite progression of non-calcified plaque, defined by annualized change in non-calcified plaque percent atheroma volume exceeding the reproducibility-based minimum detectable change (MDC95). Model discrimination will be assessed by area under the receiver operating characteristic curve and compared with conventional CCTA models. Approximately 326 participants are planned.
Detailed description
The study uses existing de-identified clinical, laboratory, and serial CCTA data. Eligible participants are adults with coronary plaque, no prior percutaneous coronary intervention or coronary artery bypass grafting, baseline and follow-up CCTA separated by at least 6 months (preferably 12 to 36 months), longitudinally matchable target segments, and adequate image quality. The baseline CCTA will be used for model prediction; the follow-up CCTA will be used for outcome ascertainment. The primary endpoint is definite patient-level non-calcified plaque progression versus non-progression. Annualized change in non-calcified plaque percent atheroma volume will be compared with an MDC95 determined in a 30-50 participant repeatability substudy. Definite progression is greater than +MDC95, stability is within +/- MDC95, and definite reduction/regression is less than -MDC95. Secondary analyses will evaluate prediction of definite plaque reduction/regression, sensitivity, specificity, positive and negative predictive values, F1 score, calibration, Brier score, decision-curve analysis, and plaque-level analyses using generalized estimating equations or mixed-effects models to account for clustering within participants. Analyses will include patient-level cross-validation, center-level validation where feasible, subgroup analyses, and prespecified sensitivity analyses by follow-up interval, scanner/reconstruction protocol, and image quality. Data will be de-identified, encrypted, access-controlled, and analyzed without additional participant procedures or costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Plaque Cohort | – | –Adults with coronary plaque identified on baseline CCTA and at least one follow-up CCTA. This observational cohort is analyzed using de-identified clinical and imaging data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with coronary plaque identified from existing clinical records and serial CCTA examinations at participating hospitals. The study uses retrospective, de-identified data and does not require additional examinations, interventions, or costs for participants.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Baseline CCTA demonstrates coronary plaque in the LAD, LCX, RCA, or a major branch with reference diameter >=2.0 mm.
- No prior percutaneous coronary intervention or coronary artery bypass grafting.
- Baseline CCTA and at least one follow-up CCTA are available, with an interval of at least 6 months, preferably 12-36 months.
- Target segments can be longitudinally matched and non-calcified plaque volume and total vessel volume can be quantified.
Key exclusion criteria (5 listed)
- Severe comorbid disease, active malignancy, acute or chronic inflammation, connective tissue or autoimmune disease, or life expectancy less than 1 year.
- Pregnancy.
- Prior PCI stent implantation or CABG.
- In-stent lesions, complete occlusion, thrombus, left main or ostial lesions, or other lesions preventing the planned hemodynamic or biomechanical analyses.
- Image quality or key data judged inadequate by the core laboratory.
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
Patient-level definite non-calcified plaque progression discrimination (AUC)
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Area under the receiver operating characteristic curve (AUC) with 95% confidence interval for the full-system model predicting definite patient-level progression of non-calcified plaque. Definite progression is annualized change in non-calcified plaque percent atheroma volume greater than +MDC95; non-progression includes stability and definite reduction/regression. AUC will be compared with conventional CCTA models using the DeLong test.
3 secondary outcomes
Prediction of definite non-calcified plaque reduction/regression (AUC and classification metrics)
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Model calibration (Brier score)
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Clinical net benefit (decision-curve analysis)
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
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 21 Oct 2026.
- Background: PubMed 27636027Symons R, Morris JZ, Wu CO, Pourmorteza A, Ahlman MA, Lima JA, Chen MY, Mallek M, Sandfort V, Bluemke DA. Coronary CT Angiography: Variability of CT Scanners and Readers in Measurement of Plaque Volume. Radiology. 2016 Dec;281(3):737-748. doi: 10.1148/radiol.2016161670. Epub 2016 Sep 16.
- Background: PubMed 15705040Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. doi: 10.1519/15184.1.
- Background: PubMed 32682451Won KB, Lee BK, Park HB, Heo R, Lee SE, Rizvi A, Lin FY, Kumar A, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Raff GL, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Quantitative assessment of coronary plaque volume change related to triglyceride glucose index: The Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry. Cardiovasc Diabetol. 2020 Jul 18;19(1):113. doi: 10.1186/s12933-020-01081-w.
- Background: PubMed 32706382Han D, Berman DS, Miller RJH, Andreini D, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Conte E, Marques H, de Araujo Goncalves P, Gottlieb I, Hadamitzky M, Leipsic J, Maffei E, Pontone G, Shin S, Kim YJ, Lee BK, Chun EJ, Sung JM, Lee SE, Virmani R, Samady H, Stone P, Narula J, Bax JJ, Shaw LJ, Lin FY, Min JK, Chang HJ. Association of Cardiovascular Disease Risk Factor Burden With Progression of Coronary Atherosclerosis Assessed by Serial Coronary Computed Tomographic Angiography. JAMA Netw Open. 2020 Jul 1;3(7):e2011444. doi: 10.1001/jamanetworkopen.2020.11444.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
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.
5 sites 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, run by Zhejiang Hospital at 5 sites 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 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 5 sites 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 Changqing Du (0571-81595231, ddcq82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-level definite non-calcified plaque progression discrimination (AUC) (time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07886996, which also lists 4 linked publications.
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 21 Oct 2026.