Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG (NCT07700524) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG
China190 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older.
* Confirmed coronary artery disease and scheduled to undergo elective isolated coronary artery bypass grafting at Nanjing Drum Tower Hospital.
* Able and willing to provide written informed consent before any study-specific procedures are performed.
Exclusion Criteria:
* Urgent, emergency, or salvage coronary artery bypass grafting.
* Prolonged preoperative fasting, as defined in the study protocol, or inability to maintain adequate oral intake without enteral or parenteral nutritional support.
* History of malignancy.
* Body weight below 50 kg.
* Preoperative hemodynamic instability requiring ongoing resuscitation or mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device support.
* Endotracheal intubation and invasive mechanical ventilation before surgery.
* Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission.
* End-stage renal disease requiring maintenance dialysis before hospital admission.
* Severe pulmonary disease considered to preclude tolerance of elective coronary artery bypass grafting or to confer an unacceptably high perioperative risk.
* Severe peripheral vascular disease or clinical evidence of limb malperfusion before surgery.
* History of gastrointestinal ulceration or chronic inflammatory gastrointestinal disease.
* Chronic inflammatory…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment
Timeframe: During the coronary artery bypass grafting procedure
2
Incidence of Adverse Events Related to the Intraoperative Ultrasound Device or Measurement Procedure
Timeframe: From the first intraoperative ultrasound measurement to 30 ± 7 days after surgery
Trial details
NCT IDNCT07700524
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School