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

NCT07700524 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Intraoperative Ultrasound Blood Flow Measurement

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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Qiang Wang, MD · Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2028-12-31
Completion
2029-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700524 on ClinicalTrials.gov