NCT07700524Not yet recruiting
Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG
Quantitative Assessment of Native Coronary Artery and Bypass Graft Blood Flow Using Intraoperative Ultrasound in Patients Undergoing Coronary Artery Bypass Grafting: A Single-Centre Prospective Feasibility and Safety Study
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 190 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Coronary artery disease
- NCT number
- NCT07700524
What you commit to
- Study type: Observational
- Planned participants: 190
- From 1 Jan 2027 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Endotracheal intubation and invasive mechanical ventilation before surgery.
- Chronic inflammatory or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs.
- Previous cardiac surgery requiring repeat median sternotomy.
- Planned concomitant major cardiac or aortic surgery, including valve surgery, congenital heart defect repair, or aortic surgery.
- Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery.
Other illness
- History of malignancy.
- 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.
- Active infection or sepsis at screening.
- Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability.
Other
- 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.
- 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.
- Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission.
- Inability to understand the study information or unwillingness or inability to provide written informed consent.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.