Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))CMI-RiskCADNCT07353762
Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease(CMI-RiskCAD)
An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
- How many people
- 10,960 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2035
- How long will I take part?
- 60 Months
- 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: Suspected CAD patients underwent CCTA
Who may be able to join
- (1)Completion of CCTA examination. (2)Age ≥ 18 years. (3)Signed written informed consent, and willing and able to comply with baseline assessment and long-term follow-up.
Who cannot join
- Acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) occurring within 72 hours; history of coronary artery bypass grafting (CABG); severe valvular heart disease; dilated or hypertrophic cardiomyopathy; congenital heart disease; or heart failure (NYHA functional class III-IV).
- Severe hepatic insufficiency (Child-Pugh class C) or renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²).
- Pregnancy or lactation.
- Life expectancy of less than 1 year, or any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.
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
Beijing Anzhen Hospital, Capital Medical University
Beijing
Chenchen Tu, +8615201648899, tcc2033@mail.ccmu.edu.cn
About this study
Official title: Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease:A Retrospective and Prospective Cohort Study
The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a), hs-CRP). First, we will develop a multimodal risk prediction model for coronary artery disease using a retrospective cohort; subsequently, we will validate the model in a prospective cohort to assess its performance in discriminating high- versus low-risk individuals and to explore its potential clinical utility for risk stratification and decision-making.
Read the detailed description
Coronary Computed Tomography Angiography (CCTA), currently the preferred non-invasive imaging modality for clinical diagnosis of coronary artery disease (CAD), not only enables intuitive assessment of coronary stenosis severity but also allows quantitative and qualitative analysis of coronary atherosclerotic plaque burden and phenotype. Quantitative CCTA integrated with artificial intelligence, particularly convolutional neural network algorithms, has achieved rapid and accurate quantitative diagnosis of atherosclerotic plaques. A large body of research has demonstrated that high-risk plaque features identified by CCTA (such as low-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign) are closely associated with the occurrence of acute coronary syndrome and can be used to predict major adverse cardiovascular events (MACEs). With advancements in image post-processing techniques, CCTA can also compute CT Fractional Flow Reserve (CT-FFR) via dedicated software, enabling non-invasive assessment of whether a lesion causes hemodynamic abnormalities and myocardial ischemia, thereby partially overcoming the limitations of purely anatomical evaluation. Notably, CCTA not only focuses on intravascular and vascular wall changes but also allows quantitative characterization of phenotypic changes in Perivascular Adipose Tissue (PVAT). By calculating the Perivascular Fat Attenuation Index (pFAI), it can reflect alterations in PVAT density and composition, indirectly indicating the inflammatory activity status of the local coronary artery wall, thus providing a novel imaging perspective for understanding CAD from the "inflammation and metabolism" viewpoint. Furthermore, CCTA can characterize the lesion patterns of coronary atherosclerosis based on physiological and geometric distribution characteristics of the vasculature. For instance, the Pullback Pressure Gradient (PPG) derived from CCTA allows comprehensive quantitative assessment of the longitudinal distribution of CAD vasculature, enabling the classification of CAD phenotypes as predominantly focal or diffuse. The CT-FFR gradient, defined as the peak instantaneous CT-FFR gradient per unit length of the vessel, has also been recently confirmed to possess incremental predictive ability for future coronary events, thereby more comprehensively describing coronary atherosclerosis in terms of both "lesion distribution pattern" and "local functional severity".
Coronary Angiography (CAG), the gold standard for diagnosing CAD, has traditionally relied on stenosis severity and SYNTAX score to assess the anatomical complexity of lesions and the difficulty of interventional treatment. However, anatomical information alone remains limited for predicting plaque stability and event risk. In recent years, emerging parameters such as Radial Wall Strain (RWS) extracted from single or multiple angiographic views have provided new tools for identifying high-risk plaques from a vascular mechanics perspective. Studies have shown that RWS can reflect the radial deformation characteristics of the arterial wall during the cardiac cycle and exhibits good correlation with vulnerable plaques and the risk of plaque rupture, holding promise as a supplementary indicator for risk stratification beyond traditional angiographic parameters.
Meanwhile, intravascular imaging techniques such as Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) can visualize plaque composition, burden, and fibrous cap morphology with high resolution, more closely approximating the pathological "vulnerable plaque" phenotype. Coronary functional assessments, such as FFR, Quantitative Flow Ratio (QFR), Murray Law-Based QFR (μFR), and Coronary Angiography-derived FFR (caFFR), evaluate from a hemodynamic perspective whether a stenosis causes functional myocardial ischemia. The continuous development of these technologies has addressed the limitation of traditional CAG, which only assesses anatomical stenosis and cannot accurately distinguish between "ischemia-causing" and "non-ischemia-causing" lesions, thereby reducing the risks of overtreatment and missed lesions. Beyond epicardial large vessel disease, Coronary Microvascular Dysfunction (CMVD) is also a significant mechanism underlying clinically common myocardial ischemia. For assessing microcirculatory function, various non-invasive or minimally invasive functional indices have emerged in recent years, such as the Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR), which comprehensively reflects myocardial ischemic burden from the perspectives of microcirculatory resistance and perfusion efficiency. This provides a novel solution to the clinical conundrum of "presence of ischemia and symptoms without significant angiographic stenosis".
In addition to imaging and functional information, routine clinical metabolic and inflammatory markers also play a crucial role in the development, progression, and prognostic evaluation of CAD. Examples include low-density lipoprotein cholesterol, triglyceride-glucose index, lipoprotein(a), glycated hemoglobin, high-sensitivity C-reactive protein, homocysteine, fasting blood glucose, and N-terminal pro-B-type natriuretic peptide. These indices reflect the body's overall metabolic status and cardiovascular risk from different dimensions, including lipid metabolism, glycolipid metabolic disorders, chronic inflammation, endothelial function, myocardial stress, and cardiac function. Studies have suggested that the combined application of metabolic and inflammatory markers with coronary imaging features facilitates more refined individualized risk stratification and prognostic prediction.
In summary, the current assessment of CAD is gradually shifting from a single focus on "anatomical stenosis" to a multidimensional comprehensive characterization encompassing "anatomical structure + functional evaluation + plaque phenotype + perivascular environment + systemic metabolic status". However, there remains a lack of systematic research on how to integrate the aforementioned multi-source information (such as CCTA plaque and functional parameters, CAG and intravascular imaging information, microcirculatory function parameters, and clinical metabolic indicators) into a unified risk prediction model, construct the model through retrospective analysis, and subsequently validate its predictive value and clinical feasibility in a prospective cohort. Therefore, this project aims to integrate coronary imaging features (including CCTA and CAG-related parameters), functional indices, and metabolic markers to construct a multimodal CAD risk prediction model. The model will be developed using a retrospective cohort and its performance validated using a prospective cohort, exploring its application value in clinical risk stratification and decision-making.
This study is led by the National Clinical Research Center for Cardiovascular Diseases and invited to be carried out by several Chinese centers including Beijing Anzhen Hospital.
- Keywords
- Coronary Computed Tomography Angiography, Perivascular Fat Attenuation Index, Coronary Angiography-derived FFR
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction
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 |
|---|---|---|
| retrospective cohort | patients with suspected CAD who underwent CCTA between 2020 and 2025 | |
| prospective cohort | patients with suspected CAD who underwent CCTA between 2026 and 2030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite endpoint of major adverse cardiovascular events (MACE)
including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.
Measured: At 12, 24, 36, 48, and 60 months after discharge
Frequency of occurrence of high-risk plaques
Frequency (%) of occurrence of high-risk plaque morphologic features (ow-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign, minimal lumen area[MLA]<4mm2)
Measured: baseline, pre-intervention
CT Fractional Flow Reserve gradient
The CT-FFR gradient is defined as the peak instantaneous CT-FFR gradient per unit vessel length, serving as an indicator of local lesion severity. The calculation of the CT-FFR gradient was performed only for lesions with diameter stenosis > 30%.
Measured: baseline, pre-intervention
Perivascular Fat Attenuation Index
The Fat Attenuation Index (FAI) was defined as the mean attenuation of perivascular adipose tissue (PVAT). The density range of adipose tissue included in the analysis was restricted to -190 HU to -30 HU, and the FAI surrounding the target vessel was automatically calculated by the software.
Measured: baseline, pre-intervention
PPG derived by follow up CCTA
pullback pressure gradient (PPG) derived by follow up CCTA, the values derived from CT-FFR were calculated using the formula
Measured: baseline, pre-intervention
SYNTAX score
In patients undergoing coronary angiography, each lesion (diameter stenosis ≥ 50%) within the coronary artery tree was quantified based on the angiographic findings
Measured: immediately after the intervention
Coronary Angiography-derived FFR and Coronary Angiography-derived Index of Microcirculatory Resistance
In patients undergoing coronary angiography, clear angiographic images of the left anterior descending (LAD), left circumflex (LCX), and right coronary arteries (RCA) were acquired from at least two different projections, ensuring no overlap or foreshortening. Three-dimensional (3D) reconstruction and hemodynamic calculations were performed using dedicated software (AccuIMR version 1.0).
Measured: baseline, pre-intervention
Radial Wall Strain
For patients undergoing coronary angiography, image frames corresponding to four key cardiac phases-late systole, early systole, late systole, and mid-diastole-were selected for a specific vessel. After segmentation and registration of the lumen contours
Measured: immediately after the intervention
IVUS-related parameters
Minimal Lumen Area, Minimal Lumen Diameter
Measured: immediately after the intervention
OCT-related parameters
Minimal Lumen Area, Lipid Core Burden Index, Fibrous Cap Thickness
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen 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
- Other
- Enrolment
- 10,960 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353762
- Sponsor's protocol ID
- BeijingAnzhen_2
- Acronym
- CMI-RiskCAD
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient privacy and ethical restrictions.
Publications
Nurmohamed NS, Min JK, Anthopolos R, Reynolds HR, Earls JP, Crabtree T, Mancini GBJ, Leipsic J, Budoff MJ, Hague CJ, O'Brien SM, Stone GW, Berger JS, Donnino R, Sidhu MS, Newman JD, Boden WE, Chaitman BR, Stone PH, Bangalore S, Spertus JA, Mark DB, Shaw LJ, Hochman JS, Maron DJ. Atherosclerosis quantification and cardiovascular risk: the ISCHEMIA trial. Eur Heart J. 2024 Sep 29;45(36):3735-3747. doi: 10.1093/eurheartj/ehae471.
PubMed 39101625
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Imaging and Metabolic Indicators-Based Risk Prediction Model for Coronary Artery Disease:A Retrospective and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07353762
- Acronym / sponsor ID
- CMI-RiskCAD / BeijingAnzhen_2
- Keywords
- Coronary Computed Tomography Angiography, Perivascular Fat Attenuation Index, Coronary Angiography-derived FFR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,960 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 20 Jan 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.
The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a), hs-CRP). First, we will develop a multimodal risk prediction model for coronary artery disease using a retrospective cohort; subsequently, we will validate the model in a prospective cohort to assess its performance in discriminating high- versus low-risk individuals and to explore its potential clinical utility for risk stratification and decision-making.
Detailed description
Coronary Computed Tomography Angiography (CCTA), currently the preferred non-invasive imaging modality for clinical diagnosis of coronary artery disease (CAD), not only enables intuitive assessment of coronary stenosis severity but also allows quantitative and qualitative analysis of coronary atherosclerotic plaque burden and phenotype. Quantitative CCTA integrated with artificial intelligence, particularly convolutional neural network algorithms, has achieved rapid and accurate quantitative diagnosis of atherosclerotic plaques. A large body of research has demonstrated that high-risk plaque features identified by CCTA (such as low-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign) are closely associated with the occurrence of acute coronary syndrome and can be used to predict major adverse cardiovascular events (MACEs). With advancements in image post-processing techniques, CCTA can also compute CT Fractional Flow Reserve (CT-FFR) via dedicated software, enabling non-invasive assessment of whether a lesion causes hemodynamic abnormalities and myocardial ischemia, thereby partially overcoming the limitations of purely anatomical evaluation. Notably, CCTA not only focuses on intravascular and vascular wall changes but also allows quantitative characterization of phenotypic changes in Perivascular Adipose Tissue (PVAT). By calculating the Perivascular Fat Attenuation Index (pFAI), it can reflect alterations in PVAT density and composition, indirectly indicating the inflammatory activity status of the local coronary artery wall, thus providing a novel imaging perspective for understanding CAD from the "inflammation and metabolism" viewpoint. Furthermore, CCTA can characterize the lesion patterns of coronary atherosclerosis based on physiological and geometric distribution characteristics of the vasculature. For instance, the Pullback Pressure Gradient (PPG) derived from CCTA allows comprehensive quantitative assessment of the longitudinal distribution of CAD vasculature, enabling the classification of CAD phenotypes as predominantly focal or diffuse. The CT-FFR gradient, defined as the peak instantaneous CT-FFR gradient per unit length of the vessel, has also been recently confirmed to possess incremental predictive ability for future coronary events, thereby more comprehensively describing coronary atherosclerosis in terms of both "lesion distribution pattern" and "local functional severity".
Coronary Angiography (CAG), the gold standard for diagnosing CAD, has traditionally relied on stenosis severity and SYNTAX score to assess the anatomical complexity of lesions and the difficulty of interventional treatment. However, anatomical information alone remains limited for predicting plaque stability and event risk. In recent years, emerging parameters such as Radial Wall Strain (RWS) extracted from single or multiple angiographic views have provided new tools for identifying high-risk plaques from a vascular mechanics perspective. Studies have shown that RWS can reflect the radial deformation characteristics of the arterial wall during the cardiac cycle and exhibits good correlation with vulnerable plaques and the risk of plaque rupture, holding promise as a supplementary indicator for risk stratification beyond traditional angiographic parameters.
Meanwhile, intravascular imaging techniques such as Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) can visualize plaque composition, burden, and fibrous cap morphology with high resolution, more closely approximating the pathological "vulnerable plaque" phenotype. Coronary functional assessments, such as FFR, Quantitative Flow Ratio (QFR), Murray Law-Based QFR (μFR), and Coronary Angiography-derived FFR (caFFR), evaluate from a hemodynamic perspective whether a stenosis causes functional myocardial ischemia. The continuous development of these technologies has addressed the limitation of traditional CAG, which only assesses anatomical stenosis and cannot accurately distinguish between "ischemia-causing" and "non-ischemia-causing" lesions, thereby reducing the risks of overtreatment and missed lesions. Beyond epicardial large vessel disease, Coronary Microvascular Dysfunction (CMVD) is also a significant mechanism underlying clinically common myocardial ischemia. For assessing microcirculatory function, various non-invasive or minimally invasive functional indices have emerged in recent years, such as the Coronary Angiography-derived Index of Microcirculatory Resistance (caIMR), which comprehensively reflects myocardial ischemic burden from the perspectives of microcirculatory resistance and perfusion efficiency. This provides a novel solution to the clinical conundrum of "presence of ischemia and symptoms without significant angiographic stenosis".
In addition to imaging and functional information, routine clinical metabolic and inflammatory markers also play a crucial role in the development, progression, and prognostic evaluation of CAD. Examples include low-density lipoprotein cholesterol, triglyceride-glucose index, lipoprotein(a), glycated hemoglobin, high-sensitivity C-reactive protein, homocysteine, fasting blood glucose, and N-terminal pro-B-type natriuretic peptide. These indices reflect the body's overall metabolic status and cardiovascular risk from different dimensions, including lipid metabolism, glycolipid metabolic disorders, chronic inflammation, endothelial function, myocardial stress, and cardiac function. Studies have suggested that the combined application of metabolic and inflammatory markers with coronary imaging features facilitates more refined individualized risk stratification and prognostic prediction.
In summary, the current assessment of CAD is gradually shifting from a single focus on "anatomical stenosis" to a multidimensional comprehensive characterization encompassing "anatomical structure + functional evaluation + plaque phenotype + perivascular environment + systemic metabolic status". However, there remains a lack of systematic research on how to integrate the aforementioned multi-source information (such as CCTA plaque and functional parameters, CAG and intravascular imaging information, microcirculatory function parameters, and clinical metabolic indicators) into a unified risk prediction model, construct the model through retrospective analysis, and subsequently validate its predictive value and clinical feasibility in a prospective cohort. Therefore, this project aims to integrate coronary imaging features (including CCTA and CAG-related parameters), functional indices, and metabolic markers to construct a multimodal CAD risk prediction model. The model will be developed using a retrospective cohort and its performance validated using a prospective cohort, exploring its application value in clinical risk stratification and decision-making.
This study is led by the National Clinical Research Center for Cardiovascular Diseases and invited to be carried out by several Chinese centers including Beijing Anzhen Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort | – | –patients with suspected CAD who underwent CCTA between 2020 and 2025 |
| prospective cohort | – | –patients with suspected CAD who underwent CCTA between 2026 and 2030 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected CAD patients underwent CCTA
Key inclusion criteria (1 listed)
- (1)Completion of CCTA examination. (2)Age ≥ 18 years. (3)Signed written informed consent, and willing and able to comply with baseline assessment and long-term follow-up.
Key exclusion criteria (4 listed)
- Acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) occurring within 72 hours; history of coronary artery bypass grafting (CABG); severe valvular heart disease; dilated or hypertrophic cardiomyopathy; congenital heart disease; or heart failure (NYHA functional class III-IV).
- Severe hepatic insufficiency (Child-Pugh class C) or renal failure (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²).
- Pregnancy or lactation.
- Life expectancy of less than 1 year, or any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.
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
The composite endpoint of major adverse cardiovascular events (MACE)
Time frame: At 12, 24, 36, 48, and 60 months after discharge
including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.
Frequency of occurrence of high-risk plaques
Time frame: baseline, pre-intervention
Frequency (%) of occurrence of high-risk plaque morphologic features (ow-attenuation plaques, positive remodeling, spotty calcification, and the napkin-ring sign, minimal lumen area[MLA]<4mm2)
CT Fractional Flow Reserve gradient
Time frame: baseline, pre-intervention
The CT-FFR gradient is defined as the peak instantaneous CT-FFR gradient per unit vessel length, serving as an indicator of local lesion severity. The calculation of the CT-FFR gradient was performed only for lesions with diameter stenosis > 30%.
Perivascular Fat Attenuation Index
Time frame: baseline, pre-intervention
The Fat Attenuation Index (FAI) was defined as the mean attenuation of perivascular adipose tissue (PVAT). The density range of adipose tissue included in the analysis was restricted to -190 HU to -30 HU, and the FAI surrounding the target vessel was automatically calculated by the software.
PPG derived by follow up CCTA
Time frame: baseline, pre-intervention
pullback pressure gradient (PPG) derived by follow up CCTA, the values derived from CT-FFR were calculated using the formula
SYNTAX score
Time frame: immediately after the intervention
In patients undergoing coronary angiography, each lesion (diameter stenosis ≥ 50%) within the coronary artery tree was quantified based on the angiographic findings
Coronary Angiography-derived FFR and Coronary Angiography-derived Index of Microcirculatory Resistance
Time frame: baseline, pre-intervention
In patients undergoing coronary angiography, clear angiographic images of the left anterior descending (LAD), left circumflex (LCX), and right coronary arteries (RCA) were acquired from at least two different projections, ensuring no overlap or foreshortening. Three-dimensional (3D) reconstruction and hemodynamic calculations were performed using dedicated software (AccuIMR version 1.0).
Radial Wall Strain
Time frame: immediately after the intervention
For patients undergoing coronary angiography, image frames corresponding to four key cardiac phases-late systole, early systole, late systole, and mid-diastole-were selected for a specific vessel. After segmentation and registration of the lumen contours
IVUS-related parameters
Time frame: immediately after the intervention
Minimal Lumen Area, Minimal Lumen Diameter
OCT-related parameters
Time frame: immediately after the intervention
Minimal Lumen Area, Lipid Core Burden Index, Fibrous Cap Thickness
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 20 Jan 2026.
- Background: PubMed 39101625Nurmohamed NS, Min JK, Anthopolos R, Reynolds HR, Earls JP, Crabtree T, Mancini GBJ, Leipsic J, Budoff MJ, Hague CJ, O'Brien SM, Stone GW, Berger JS, Donnino R, Sidhu MS, Newman JD, Boden WE, Chaitman BR, Stone PH, Bangalore S, Spertus JA, Mark DB, Shaw LJ, Hochman JS, Maron DJ. Atherosclerosis quantification and cardiovascular risk: the ISCHEMIA trial. Eur Heart J. 2024 Sep 29;45(36):3735-3747. doi: 10.1093/eurheartj/ehae471.
- Individual participant dataSharing planned: No. Due to patient privacy and ethical restrictions.
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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 (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Beijing Anzhen 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 1 inclusion and 4 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 20 Jan 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 Chenchen Tu (+8615201648899, tcc2033@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite endpoint of major adverse cardiovascular events (MACE) (time frame: At 12, 24, 36, 48, and 60 months after discharge). The study lists 10 primary outcomes in all. 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 NCT07353762, which also lists 1 linked publication.
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 Jan 2026.