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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07700524
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative Ultrasound Blood Flow Measurement — DIAGNOSTIC_TEST
    Intraoperative ultrasound measurements of major native coronary arteries will be obtained before and after revascularisation, followed by measurements of individual bypass grafts after restoration of blood flow. Recorded variables will include blood flow velocity, volumetric blood flow and other protocol-defined quantitative parameters. The findings will be collected for research purposes and will not guide graft revision or other intraoperative clinical decisions.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Jan 1, 2027
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
190 participants (estimated)

Arms

  • Arm: Intraoperative Ultrasound CABG Cohort
    This cohort will prospectively include adults undergoing elective isolated coronary artery bypass grafting. Ultrasound-derived blood flow parameters of native coronary arteries and bypass grafts will be collected at prespecified intraoperative time points. Transit-time flow measurements, perioperative data, postoperative cardiac function and myocardial injury biomarkers will also be collected. No parallel control cohort will be established, and the research ultrasound findings will not influence intraoperative clinical decision-making.

Primary Outcome Measure

Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment [ Time Frame: During the coronary artery bypass grafting procedure ]

Central Contacts

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