Coronary Artery DiseaseNCT07311954
Development and Validation of a cCTA and Biomarker Based Risk Model for Coronary Revascularization in Elderly Patients With Coronary Artery Disease
An observational study of Coronary Artery Disease and Elderly (Aged >70), run by China National Center for Cardiovascular Diseases.
Trial summary
This study is a prospective multi-center observational cohort involving elderly patients (≥70 years old) with multi-vessel coronary disease identified by coronary computed tomography angiography (cCTA) and scheduled for invasive coronary angiography. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Coronary Artery Disease, Elderly (Aged >70)
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2029
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients aged 70 years and older with multivessel coronary artery disease identified by coronary CT angiography and scheduled to undergo invasive coronary angiography at participating centers.
Who may be able to join
- Age ≥ 70 years.
- Multivessel coronary artery disease identified on coronary computed tomography angiography (CCTA), defined as ≥50% stenosis in at least two of the three major epicardial coronary arteries.
- Scheduled to undergo invasive coronary angiography as part of standard clinical care.
- Able to provide informed consent, or consent provided by a legally authorized representative.
Who cannot join
- Previous coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- Acute myocardial infarction at admission, according to electrocardiographic findings and elevated cardiac biomarkers consistent with acute MI.
- Poor-quality CCTA images that prevent accurate assessment of coronary plaque characteristics or stenosis severity.
- Refusal or inability to participate in the study or to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a prospective multi-center observational cohort involving elderly patients (≥70 years old) with multi-vessel coronary disease identified by coronary computed tomography angiography (cCTA) and scheduled for invasive coronary angiography. Data collection about cCTA, frailty and biomarkers and two-year follow-up will be conducted to develop and validate a risk model of coronary revascularization.
- Conditions
- Coronary Artery Disease, Elderly (Aged >70)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- coronary computed tomography angiography, frailty, biomarker
- Medical subject headings
- Coronary Artery Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Model Development and Validation Cohort | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC) for Risk Model Performance
AUC evaluates the model's discrimination performance in predicting MACCEs at 24 months.
Measured: At completion of 2-year follow-up
Secondary outcomes (7)
Sensitivity of the Prediction Model
The proportion of participants who actually experienced MACCEs (Major Adverse Cardiac and Cerebral Events) that were correctly identified by the prediction model as high risk.
Measured: At completion of 2-year follow-up
Specificity of the Prediction Model
The proportion of participants who did not experience MACCEs that were correctly identified by the prediction model as low risk.
Measured: At completion of 2-year follow-up
Positive Predictive Value (PPV)
The probability that subjects identified by the model as high risk truly experienced the adverse events (MACCEs).
Measured: At completion of 2-year follow-up
Negative Predictive Value (NPV)
The probability that subjects identified by the model as low risk truly did not experience the adverse events.
Measured: At completion of 2-year follow-up
Hosmer-Lemeshow Goodness-of-Fit Statistic
A statistical test to assess the calibration of the model. It evaluates whether the observed event rates match the expected event rates in subgroups of the model population. A non-significant p-value indicates good fit.
Measured: At completion of 2-year follow-up
Calibration Slope
Assessment of the agreement between observed outcomes and predicted risks. A slope (beta) of 1 indicates ideal calibration.
Measured: At completion of 2-year follow-up
Decision Curve Analysis (DCA)
Evaluation of clinical net benefit across a range of threshold probabilities.
Measured: At completion of 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (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 China National Center for Cardiovascular DiseasesThe 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
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311954
- Sponsor's protocol ID
- 2025-2970
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a cCTA and Biomarker Based Risk Model for Coronary Revascularization in Elderly Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07311954
- Acronym / sponsor ID
- 2025-2970
- Conditions
- Coronary Artery Disease, Elderly (Aged >70)
- Keywords
- coronary computed tomography angiography, frailty, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 31 Dec 2025 (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 study is a prospective multi-center observational cohort involving elderly patients (≥70 years old) with multi-vessel coronary disease identified by coronary computed tomography angiography (cCTA) and scheduled for invasive coronary angiography. Data collection about cCTA, frailty and biomarkers and two-year follow-up will be conducted to develop and validate a risk model of coronary revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model Development and Validation Cohort | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged 70 years and older with multivessel coronary artery disease identified by coronary CT angiography and scheduled to undergo invasive coronary angiography at participating centers.
Key inclusion criteria (4 listed)
- Age ≥ 70 years.
- Multivessel coronary artery disease identified on coronary computed tomography angiography (CCTA), defined as ≥50% stenosis in at least two of the three major epicardial coronary arteries.
- Scheduled to undergo invasive coronary angiography as part of standard clinical care.
- Able to provide informed consent, or consent provided by a legally authorized representative.
Key exclusion criteria (4 listed)
- Previous coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- Acute myocardial infarction at admission, according to electrocardiographic findings and elevated cardiac biomarkers consistent with acute MI.
- Poor-quality CCTA images that prevent accurate assessment of coronary plaque characteristics or stenosis severity.
- Refusal or inability to participate in the study or to provide informed consent.
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention will be conducted. | Other | Model Development and Validation Cohort |
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUC) for Risk Model Performance
Time frame: At completion of 2-year follow-up
AUC evaluates the model's discrimination performance in predicting MACCEs at 24 months.
7 secondary outcomes
Sensitivity of the Prediction Model
Time frame: At completion of 2-year follow-up
Specificity of the Prediction Model
Time frame: At completion of 2-year follow-up
Positive Predictive Value (PPV)
Time frame: At completion of 2-year follow-up
Negative Predictive Value (NPV)
Time frame: At completion of 2-year follow-up
Hosmer-Lemeshow Goodness-of-Fit Statistic
Time frame: At completion of 2-year follow-up
Calibration Slope
Time frame: At completion of 2-year follow-up
Decision Curve Analysis (DCA)
Time frame: At completion of 2-year follow-up
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 31 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Elderly (Aged >70), run by China National Center for Cardiovascular Diseases.
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 4 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhe Zheng, MD, PhD (+86 88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUC) for Risk Model Performance (time frame: At completion of 2-year follow-up). 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 31 Dec 2025.