An observational study in Coronary Artery Bypass Grafting (CABG) Surgery and Coronary Artery Disease, sponsored by Xin Lou. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Xin Lou · Observational
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:
Clinical doctors will determine surgery and treatment based on each participant's medical needs.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 150 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Xin Lou is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before CABG and within 7 days after CABG
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2029, 48 months after the start.
Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 48 months is close to that.
Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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