Coronary Artery DiseaseCtaCABNCT07769008
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
A study testing CCTA-based CABG and CAG-based CABG in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Computed Tomography Angiography
- What is being tested?
- CCTA-based CABG and CAG-based CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to Aug 2029
- 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
- Referred to CABG treatment
Who cannot join
- Under the age of 18 years
- Unable to provide informed consent
- Emergency CABG
- Redo-CABG
- Prior PCI with coronary stent implantation
- Cardiogenic shock
Show all 10Show fewer
- Unable to undergo CAG or CCTA examination or deemed unsuitable by the investigator, such as:
- Known allergy to iodinated contrast media; Active hyperthyroidism or uncontrolled thyroid disease; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²; Atrial fibrillation with rapid ventricular response or severe arrhythmias not amenable to rate control;
- Pregnancy, lactation, or childbearing potential without effective contraception in female participants
- Concurrent participation in another interventional trial
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
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Yunpeng Zhu, MD, 0086-02164370045, zyp12220@rjh.com.cn
Yunpeng Zhu, MD
About this study
Official title: Coronary Computed Tomography Angiography-Based Versus Coronary Angiography-Based Coronary Artery Bypass Grafting: A Multicenter Pragmatic Non-Inferiority Randomized Controlled Trial
The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries.
The main questions it aims to answer are:
Read more
Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol.
Participants will:
Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Computed Tomography Angiography, Coronary Angiography (CAG)
- Being tested
- CCTA-based CABG, CAG-based CABG
- Keywords
- Major Adverse Cardiovascular Events (MACE), Coronary Artery Bypass Grafting (CABG), Coronary Computed Tomography Angiography(CCTA), Coronary Angiography(CAG)
- 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.
CCTA-based CABGProcedure or surgery
Surgical planning based solely on CCTA-derived data, including diameter stenosis (DS), area stenosis (AS), CT-derived fractional flow reserve (CT-FFR), LV:RV perfusion index, plaque characterization, 3D reconstruction of target vessels, and collateral circulation of chronic total occlusions (CTO) and so on.
CCTA performed using photon-counting CT or conventional CT (≥64-slice, preferably ≥256-slice), following a standardized acquisition protocol. Images are transferred to an independent core laboratory for quantitative analysis and standardized reporting.
The operating surgeon will not have access to CAG.
CAG-based CABGProcedure or surgery
Surgical planning following standard practice using invasive coronary angiography(CAG). Angiograms obtained using a flat-panel detector system with standardized projections. The results of CAG are interpreted by the operating surgeon.The operating surgeon will not have access to CCTA.
| Study group | Role | What they receive |
|---|---|---|
| CCTA-Based CABG | Experimental | Not described Receives: Procedure: CCTA-based CABG |
| CAG-Based CABG | Active comparator | Not described Receives: Procedure: CAG-based CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)
The 5P-MACE was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and CABG-related or cardiovascular-related prolonged postoperative length of stay (PLOS) or rehospitalization.
Measured: Within 1 year post-CABG
Secondary outcomes (10)
1-year incidence of all-cause death
Measured: Within 1 year post-CABG
1-year incidence of CV death
Measured: within 1 year post-CABG
1-year incidence of MI
Measured: Within 1 year post-CABG
1-year incidence of stroke
Measured: Within 1 year post-CABG
1-year incidence of unplanned revascularization
Measured: Within 1 year post-CABG
1-year incidence of CABG-related or CV-related prolonged PLOS or rehospitalization.
Measured: Within 1 year post-CABG
30-day incidence of the operative mortality and morbidity
The operative mortality and morbidity was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, cardiac arrest, reoperation, prolonged ventilation, deep sternal wound infection, pacemaker implantation, major gastrointestinal bleeding, and new dialysis .
Measured: Within 30 days post-CABG
7-day graft failure rate
Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.
Measured: At 7 day post-CABG
1-year graft failure rate
Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.
Measured: At 1 year post-CABG
Other serious adverse events (SAE)
Important medical events that impact subjects' daily life or health and require appropriate intervention, but are not part of the primary or secondary outcome definitions above
Measured: Within 1 year post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start17 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 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 Ruijin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu yunpeng, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769008
- Sponsor's protocol ID
- KY-2026-523
- Acronym
- CtaCAB
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography Angiography-Based Versus Coronary Angiography-Based Coronary Artery Bypass Grafting: A Multicenter Pragmatic Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07769008
- Acronym / sponsor ID
- CtaCAB / KY-2026-523
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Computed Tomography Angiography, Coronary Angiography (CAG)
- Keywords
- Major Adverse Cardiovascular Events (MACE), Coronary Artery Bypass Grafting (CABG), Coronary Computed Tomography Angiography(CCTA), Coronary Angiography(CAG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 826 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 Aug 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 goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries.
The main questions it aims to answer are:
Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol.
Participants will:
Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCTA-Based CABG | Experimental | Procedure: CCTA-based CABG |
| CAG-Based CABG | Active comparator | Procedure: CAG-based CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred to CABG treatment
Key exclusion criteria (10 listed)
- Under the age of 18 years
- Unable to provide informed consent
- Emergency CABG
- Redo-CABG
- Prior PCI with coronary stent implantation
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 |
|---|---|---|
| CCTA-based CABGSurgical planning based solely on CCTA-derived data, including diameter stenosis (DS), area stenosis (AS), CT-derived fractional flow reserve (CT-FFR), LV:RV perfusion index, plaque characterization, 3D reconstruction of target vessels, and collateral circulation of chronic total occlusions (CTO) and so on. CCTA performed using photon-counting CT or conventional CT (≥64-slice, preferably ≥256-slice), following a standardized acquisition protocol. Images are transferred to an independent core laboratory for quantitative analysis and standardized reporting. The operating surgeon will not have access to CAG. | Procedure or surgery | CCTA-Based CABG |
| CAG-based CABGSurgical planning following standard practice using invasive coronary angiography(CAG). Angiograms obtained using a flat-panel detector system with standardized projections. The results of CAG are interpreted by the operating surgeon.The operating surgeon will not have access to CCTA. | Procedure or surgery | CAG-Based CABG |
Primary outcome
1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)
Time frame: Within 1 year post-CABG
The 5P-MACE was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and CABG-related or cardiovascular-related prolonged postoperative length of stay (PLOS) or rehospitalization.
10 secondary outcomes
1-year incidence of all-cause death
Time frame: Within 1 year post-CABG
1-year incidence of CV death
Time frame: within 1 year post-CABG
1-year incidence of MI
Time frame: Within 1 year post-CABG
1-year incidence of stroke
Time frame: Within 1 year post-CABG
1-year incidence of unplanned revascularization
Time frame: Within 1 year post-CABG
1-year incidence of CABG-related or CV-related prolonged PLOS or rehospitalization.
Time frame: Within 1 year post-CABG
30-day incidence of the operative mortality and morbidity
Time frame: Within 30 days post-CABG
7-day graft failure rate
Time frame: At 7 day post-CABG
1-year graft failure rate
Time frame: At 1 year post-CABG
Other serious adverse events (SAE)
Time frame: Within 1 year post-CABG
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 19 Aug 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?
A study testing CCTA-based CABG and CAG-based CABG in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Ruijin 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 10 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 19 Aug 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 Yunpeng Zhu, MD (0086-02164370045, zyp12220@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE) (time frame: Within 1 year post-CABG). 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 19 Aug 2026.