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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Feb 28, 2028 → Dec 31, 2028
Primary endpoint reworded 2 of 2 changed
Enrollment reduced 50% 380 → 190 participants
See other at-risk trials from The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Record History

  1. Primary completion pushed from Feb 28, 2028 to Dec 31, 2028 Primary endpoint(s) modified · Enrollment reduced: 380 → 190 participants · Start date: Aug 1, 2026 to Jan 1, 2027 · 7 morev2 Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 380 → 190 participants
    • Start date: Aug 1, 2026 to Jan 1, 2027
    • Completion pushed from Feb 28, 2029 to Dec 30, 2029
    • Trial arms changed: 2 → 1
    • Interventions: Intraoperative Portable Doppler Ultrasound (Diagnostic Test) to Intraoperative Ultrasound Blood Flow Measurement (Diagnostic Test)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 8 to 4
    • Study description expanded, about 192 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov