Clinical Trial

Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG

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Summary
This single-centre, prospective observational feasibility and safety study will enrol 190 consecutive adults undergoing elective isolated coronary artery bypass grafting (CABG) at Nanjing Drum Tower Hospital. The study aims to evaluate the feasibility and safety of intraoperative ultrasound for the quantitative assessment of native coronary artery and bypass graft blood flow. Transit-time flow measurement will be performed as part of routine intraoperative graft assessment. Additional ultrasound measurements will be obtained from major native coronary arteries before and after revascularisation and from bypass grafts after restoration of blood flow. The ultrasound findings will be collected for research purposes and will not influence graft revision or other intraoperative clinical decisions. The co-primary outcomes are the participant-level technical success rate of the protocol-defined intraoperative ultrasound assessment and the incidence of adverse events related to the ultrasound device or measurement procedure. Secondary outcomes include agreement between ultrasound and transit-time flow measurements, changes in native coronary artery blood flow after revascularisation, measurement repeatability, and exploratory associations between intraoperative flow parameters and postoperative cardiac function and myocardial injury biomarkers. Participants will be followed for 30 ± 7 days after surgery.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-08-12
notable Enrollment reduced: 380 -> 190 participants 2026-08-12
minor Trial arms changed: 2 -> 1 2026-08-12
notable Primary completion pushed: 2028-02-28 -> 2028-12-31 2026-08-12
minor Completion pushed: 2029-02-28 -> 2029-12-30 2026-08-12
Trial Details
NCT Number NCT07700524
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions Coronary Artery Disease
Enrollment 190 participants
Start Date 2027-01-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11