Coronary Artery Bypass Grafting (CABG) SurgeryPCCT-CABGNCT07883499
Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG
An observational study of Coronary Artery Bypass Grafting (CABG) Surgery and Coronary Artery Disease, run by Xin Lou at 1 site in China.
Trial summary
The goal of this observational study is to learn whether information about heart muscle tissue from preoperative photon-counting CT, a newer type of CT scan, can help predict heart recovery 3 months after coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Bypass Grafting (CABG) Surgery, Coronary Artery Disease
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 10 Oct 2029
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for isolated CABG at the study center will be screened consecutively. Eligibility decisions, consent status, and reasons for non-enrollment will be recorded for all screened patients to avoid restricting enrollment to those with good image quality or completed follow-up.
Who may be able to join
- Age ≥18 years and scheduled for isolated CABG.
- Able to undergo the protocol-specified PCCT examinations after assessment by the clinical and imaging teams.
- Able to understand the study and provide written informed consent, and willing to attend the 3-month postoperative follow-up.
Who cannot join
- Planned concomitant major cardiac surgery, such as valve or aortic surgery, that places the patient outside the target population of isolated CABG.
- A clinically assessed contraindication to contrast-enhanced CT, including a severe iodinated contrast allergy that cannot be adequately managed, pregnancy, or another examination contraindication.
- Clinical condition precluding research examinations, or a research workflow that could delay necessary treatment.
- Unable to complete the informed consent process or explicitly unwilling to attend the required follow-up.
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
Department of Radiology, the First Medical Center of Chinese PLA General Hospital/ Chinese PLA Medical School, Beijing, China
Beijing
Xiaomeng Fan, 18515817177, fanxiaomeng@301hospital.com.cn
About this study
Official title: Prospective Study Protocol for Multiparametric Photon Counting CT Assessment of Early Ventricular Outcomes After Coronary Artery Bypass Grafting
The goal of this observational study is to learn whether information about heart muscle tissue from preoperative photon-counting CT, a newer type of CT scan, can help predict heart recovery 3 months after coronary artery bypass surgery. The study will include adults aged 18 years or older with coronary artery disease who are scheduled for coronary artery bypass surgery without another major heart operation.
The main question it aims to answer is:
Read more
- Can heart muscle information from CT before surgery help predict the amount of blood remaining in the heart's left pumping chamber after it contracts, adjusted for body size, 3 months after surgery? This measurement is called the left ventricular end-systolic volume index and will be used to assess early changes in heart structure after surgery.
Participants will:
- Have photon-counting CT scans and heart ultrasound examinations before surgery, within 7 days after surgery, and approximately 3 months after surgery.
- Have blood tests before surgery and within 7 days afterward to help researchers assess changes in heart muscle tissue.
- Provide information about medications, hospital admissions, and their health during follow-up.
Clinical doctors will determine surgery and treatment based on each participant's medical needs.
- 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 |
|---|---|---|
| Adults scheduled for isolated CABG at the study center will be screened consecutively. Eligibility d | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-systolic volume index at 3 months after CABG
Left ventricular end-systolic volume index at 3 months after coronary artery bypass grafting Left ventricular end-systolic volume index at 3 months after coronary artery bypass grafting
Measured: Three months after surgery. The proposed window is postoperative day 90 ±14 days and must be confirmed before protocol finalization and ethics approval.
Secondary outcomes (9)
Inter-reader relative absolute difference in equivalent lumen diameter
Equivalent lumen diameter will be measured independently by two readers at matched anatomical locations on each prespecified PCCT reconstruction. The relative absolute difference will be calculated as the absolute difference between readers divided by their mean, multiplied by 100%. Measurements will be summarized per graft and then equally weighted per patient. Results will be compared between the prespecified reconstruction protocols.
Measured: Within 7 days after CABG
Absolute difference in diameter stenosis between PCCT and quantitative coronary angiography
In the preoperative ICA validation subgroup, diameter stenosis measured by PCCT will be compared with quantitative coronary angiography at matched native coronary artery or previously stented lesions. The absolute difference will be expressed in percentage points. PCCT and ICA examinations will be no more than 30 days apart, with no relevant intervention or acute event between examinations.
Measured: Before CABG, with PCCT and ICA performed no more than 30 days apart
Absolute error of CFD-estimated mean graft flow relative to intraoperative TTFM
For grafts with matched final intraoperative TTFM records, the absolute difference between CFD-estimated mean flow and TTFM-measured mean flow will be calculated in mL/min. Fixed-geometry and dynamic-geometry models will be compared within the same graft. TTFM will remain independent of model fitting. The comparison will account for the different measurement time points.
Measured: Signed difference between CFD-estimated mean graft flow and intraoperative TTFM
Relative change in bypass graft lumen area at 3 months
For grafts patent on the early postoperative examination, lumen area will be measured at matched anatomical locations using comparable reconstruction and cardiac-phase settings. Relative change will be calculated as the 3-month area minus the early postoperative area, divided by the early postoperative area, multiplied by 100%. Newly occluded grafts will be recorded separately rather than excluded without explanation.
Measured: Within 7 days after CABG and at 3 months after CABG
Change in left ventricular myocardial extracellular volume fraction
Left ventricular myocardial ECV will be calculated from delayed PCCT iodine maps and contemporaneous hematocrit using a standardized myocardial segmentation method. Change will be calculated as postoperative ECV minus preoperative ECV and expressed in percentage points.
Measured: Before CABG and within 7 days after CABG
Change in left ventricular late iodine enhancement burden
LIE burden will be quantified as the percentage of total left ventricular myocardial volume exhibiting late iodine enhancement. Change will be calculated as postoperative LIE burden minus preoperative LIE burden and expressed in percentage points. The same detection and segmentation rules will be used at both examinations.
Measured: Before CABG and within 7 days after CABG
Change in left ventricular ejection fraction
LVEF will be measured from full cardiac-cycle PCCT using standardized ventricular segmentation. Change from the preoperative value will be calculated separately for the early postoperative and 3-month examinations and expressed in percentage points. Contemporaneous echocardiography will provide comparison measurements.
Measured: Before CABG, within 7 days after CABG, and at 3 months after CABG
Change in left ventricular global longitudinal strain
Left ventricular GLS will be measured using CT feature tracking with the same software and strain sign convention across examinations. Change from the preoperative value will be calculated separately for the early postoperative and 3-month examinations and expressed in percentage points.
Measured: Before CABG, within 7 days after CABG, and at 3 months after CABG
Change in left ventricular end-diastolic volume index
Left ventricular end-diastolic volume will be measured from full cardiac-cycle PCCT and divided by body surface area. Change will be calculated as the early postoperative LVEDVi minus the preoperative value and expressed in mL/m². The same segmentation and body surface area calculation rules will be used.
Measured: Before CABG and within 7 days after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start10 Oct 2025
- Primary completion10 Oct 2029 (estimated)
- Study completion10 Oct 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 Bypass Grafting (CABG) SurgeryStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xin Lou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, Study chair, Department of Radiology, the First Medical Center of Chinese PLA General Hospital/ Chinese PLA Medical School, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883499
- Sponsor's protocol ID
- Multiparame PCCT in Post-CABG
- Acronym
- PCCT-CABG
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Protocol for Multiparametric Photon Counting CT Assessment of Early Ventricular Outcomes After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07883499
- Acronym / sponsor ID
- PCCT-CABG / Multiparame PCCT in Post-CABG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xin LouUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Oct 2029 (estimated)
- Study completion
- 10 Oct 2029 (estimated)
- First posted
- 20 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.
The goal of this observational study is to learn whether information about heart muscle tissue from preoperative photon-counting CT, a newer type of CT scan, can help predict heart recovery 3 months after coronary artery bypass surgery. The study will include adults aged 18 years or older with coronary artery disease who are scheduled for coronary artery bypass surgery without another major heart operation.
The main question it aims to answer is:
- Can heart muscle information from CT before surgery help predict the amount of blood remaining in the heart's left pumping chamber after it contracts, adjusted for body size, 3 months after surgery? This measurement is called the left ventricular end-systolic volume index and will be used to assess early changes in heart structure after surgery.
Participants will:
- Have photon-counting CT scans and heart ultrasound examinations before surgery, within 7 days after surgery, and approximately 3 months after surgery.
- Have blood tests before surgery and within 7 days afterward to help researchers assess changes in heart muscle tissue.
- Provide information about medications, hospital admissions, and their health during follow-up.
Clinical doctors will determine surgery and treatment based on each participant's medical needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults scheduled for isolated CABG at the study center will be screened consecutively. Eligibility d | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for isolated CABG at the study center will be screened consecutively. Eligibility decisions, consent status, and reasons for non-enrollment will be recorded for all screened patients to avoid restricting enrollment to those with good image quality or completed follow-up.
Key inclusion criteria (3 listed)
- Age ≥18 years and scheduled for isolated CABG.
- Able to undergo the protocol-specified PCCT examinations after assessment by the clinical and imaging teams.
- Able to understand the study and provide written informed consent, and willing to attend the 3-month postoperative follow-up.
Key exclusion criteria (4 listed)
- Planned concomitant major cardiac surgery, such as valve or aortic surgery, that places the patient outside the target population of isolated CABG.
- A clinically assessed contraindication to contrast-enhanced CT, including a severe iodinated contrast allergy that cannot be adequately managed, pregnancy, or another examination contraindication.
- Clinical condition precluding research examinations, or a research workflow that could delay necessary treatment.
- Unable to complete the informed consent process or explicitly unwilling to attend the required follow-up.
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
Left ventricular end-systolic volume index at 3 months after CABG
Time frame: Three months after surgery. The proposed window is postoperative day 90 ±14 days and must be confirmed before protocol finalization and ethics approval.
Left ventricular end-systolic volume index at 3 months after coronary artery bypass grafting Left ventricular end-systolic volume index at 3 months after coronary artery bypass grafting
9 secondary outcomes
Inter-reader relative absolute difference in equivalent lumen diameter
Time frame: Within 7 days after CABG
Absolute difference in diameter stenosis between PCCT and quantitative coronary angiography
Time frame: Before CABG, with PCCT and ICA performed no more than 30 days apart
Absolute error of CFD-estimated mean graft flow relative to intraoperative TTFM
Time frame: Signed difference between CFD-estimated mean graft flow and intraoperative TTFM
Relative change in bypass graft lumen area at 3 months
Time frame: Within 7 days after CABG and at 3 months after CABG
Change in left ventricular myocardial extracellular volume fraction
Time frame: Before CABG and within 7 days after CABG
Change in left ventricular late iodine enhancement burden
Time frame: Before CABG and within 7 days after CABG
Change in left ventricular ejection fraction
Time frame: Before CABG, within 7 days after CABG, and at 3 months after CABG
Change in left ventricular global longitudinal strain
Time frame: Before CABG, within 7 days after CABG, and at 3 months after CABG
Change in left ventricular end-diastolic volume index
Time frame: Before CABG and within 7 days after 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 20 Oct 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.
Xin Lou study chair
Department of Radiology, the First Medical Center of Chinese PLA General Hospital/ Chinese PLA Medical School, Beijing, China
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 Bypass Grafting (CABG) Surgery and Coronary Artery Disease, run by Xin Lou 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 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: looking for participants now, as of the sponsor's last update on 20 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 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 Xiaomeng Fan (18515817177, fanxiaomeng@301hospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end-systolic volume index at 3 months after CABG (time frame: Three months after surgery. The proposed window is postoperative day 90 ±14 days and must be confirmed before protocol finalization and ethics approval.). 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 20 Oct 2026.