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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment
研究概览
简要总结
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.
详细描述
Intraoperative assessment of bypass graft function is important for ensuring adequate myocardial revascularisation during coronary artery bypass grafting. Transit-time flow measurement is widely used for graft assessment but primarily evaluates blood flow within bypass grafts and provides limited information on changes in native coronary artery blood flow before and after revascularisation.
This study will evaluate a portable ultrasound platform with access to programmable raw radiofrequency data. The study-specific procedure consists of additional intraoperative ultrasound measurements obtained from the exposed epicardial surface without additional incision, vascular puncture or tissue penetration. Major native coronary arteries will be assessed before and after revascularisation, and individual bypass grafts will be assessed after completion of the graft anastomoses and restoration of blood flow. Transit-time flow measurements will be recorded according to routine clinical practice for subsequent agreement analyses.
The research ultrasound findings will not be used to guide graft revision, repeat anastomosis or other intraoperative clinical decisions. The study is designed to evaluate technical feasibility, safety, agreement with transit-time flow measurement, measurement repeatability and changes in native coronary artery blood flow. Associations between intraoperative flow parameters and postoperative cardiac function and myocardial injury biomarkers will be exploratory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs.
- •Active infection or sepsis at screening.
- •Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability.
- •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 to understand the study information or unwillingness or inability to provide written informed consent.
- •Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
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.
干预措施: Intraoperative Ultrasound Blood Flow Measurement (Diagnostic Test)
结局指标
主要结局
Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment
时间窗: During the coronary artery bypass grafting procedure
The proportion of enrolled participants with analysable quantitative flow parameters obtained from ultrasound measurements of at least two major native coronary arteries both before and after revascularisation and from all protocol-specified independent bypass grafts. Failure to initiate or complete a protocol-defined measurement, visualise a required target vessel, obtain a stable flow signal, or generate analysable data will be classified as technical failure and retained in the denominator.
Incidence of Adverse Events Related to the Intraoperative Ultrasound Device or Measurement Procedure
时间窗: From the first intraoperative ultrasound measurement to 30 ± 7 days after surgery
The proportion of participants with any adverse event judged by the investigator as possibly, probably, or definitely related to the intraoperative ultrasound device or measurement procedure. Prespecified events of special interest include a new or worsened sustained arrhythmia requiring treatment; clinically significant haemodynamic instability; bleeding or tissue injury attributable to probe contact or manipulation; native coronary artery, graft, or anastomotic injury; interruption or clinically meaningful prolongation of surgery attributable to ultrasound measurement; device malfunction posing a patient safety risk; and other related events as judged by the investigator.
次要结局
- Agreement Between Intraoperative Ultrasound and Transit-Time Flow Measurements(During CABG, after completion of graft anastomoses and restoration of blood flow)
- Mean Within-Vessel Change in Ultrasound-Derived Volumetric Blood Flow of Native Coronary Arteries Before and After Revascularisation(During CABG: immediately before revascularisation and after completion of graft anastomoses following haemodynamic stabilisation)
- Repeatability of Intraoperative Ultrasound Blood Flow Measurements(During the coronary artery bypass grafting procedure)
- Association of Intraoperative Blood Flow Parameters With Postoperative Cardiac Function and Myocardial Injury Biomarkers(From the preoperative baseline assessment to 30 ± 7 days after surgery)