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This single-center, randomized, controlled trial aims to evaluate whether intraoperative portable ultrasound monitoring can improve early postoperative outcomes in patients undergoing coronary artery bypass grafting (CABG).
A total of 380 patients scheduled for elective CABG at Nanjing Drum Tower Hospital will be randomly assigned in a 1:1 ratio to either the ultrasound group or the control group. In the ultrasound group, a trained surgeon or researcher will use a portable ultrasound device to assess distal graft perfusion and each coronary artery perfusion in real time before and after completion of graft anastomosis. In the control group, graft function is evaluated by the surgeon's standard clinical judgment without ultrasound monitoring.
The primary outcomes are two composite endpoints: (1) a composite of major adverse clinical events including operative death, perioperative myocardial ischemia or infarction, low cardiac output syndrome, stroke, acute kidney injury requiring dialysis, need for mechanical circulatory support, unplanned cardiac reoperation, cardiac arrest, multiorgan failure, prolonged mechanical ventilation (>72 hours), and postoperative hospital stay ≥30 days; and (2) a composite of ultrasound-detected graft perfusion abnormalities including diminished or absent graft flow signal, new segmental wall motion abnormalities, decline in left ventricular ejection fraction (LVEF) ≥10% from baseline, and graft-related reintervention.
Secondary outcomes include longitudinal changes in laboratory biomarkers (hematology, inflammation, coagulation, liver and renal function, myocardial injury, and cardiac function), intraoperative and perioperative surgical parameters, and diagnostic accuracy of ultrasound compared with postoperative imaging.
All participants will receive standard CABG surgery and perioperative care. Results are expected to provide evidence on the clinical utility of intraoperative ultrasound for real-time perfusion assessment during CABG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable Ultrasound Real-time Monitoring Group | After completion of graft anastomosis, a trained surgeon or researcher uses a portable ultrasound device to perform real-time assessment of distal graft perfusion, each coronary artery perfusion and records relevant ultrasound parameters. If any potential adverse event related to ultrasound operation or any obvious interference with surgical safety occurs, the ultrasound assessment will be immediately terminated, the subject will be withdrawn from the study, and the event will be documented and reported according to regulations. This arm enrolls 190 patients. |
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| Conventional Surgery Control Group | Patients in this arm do not receive intraoperative portable ultrasound assessment. Graft function is evaluated solely by the surgeon's experience and routine intraoperative methods (e.g., palpation, flow measurement) as per standard practice. All other surgical procedures and perioperative management are identical to those in the experimental group. This arm enrolls 190 patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Portable Doppler Ultrasound | Diagnostic Test | Intraoperative real-time assessment of distal graft perfusion and each coronary artery perfusion using a portable ultrasound device before and after completion of coronary artery bypass anastomosis. Ultrasound parameters are recorded for each artery. The procedure is performed by trained surgeons or researchers. In case of any ultrasound-related adverse event or safety concern, the assessment is terminated immediately. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Major Adverse Clinical Events | Composite of the following events: (1) operative death; (2) perioperative myocardial perfusion adverse events (including perioperative myocardial ischemia or infarction, low cardiac output syndrome); (3) severe neurological complications (including stroke or persistent postoperative neurological deficit); (4) acute kidney injury requiring temporary or permanent dialysis; (5) postoperative need for mechanical circulatory support (e.g., IABP or ECMO); (6) unplanned cardiac reoperation (excluding reoperation for bleeding alone); (7) postoperative cardiac arrest, multiple organ failure, or mechanical ventilation > 72 hours; (8) postoperative hospital stay ≥ 30 days. | From surgery up to 30 days postoperatively |
| Composite of Ultrasound-Detected Graft Perfusion Abnormalities | Composite of the following events: (1) significantly diminished or absent flow signal in the graft by portable ultrasound; (2) new segmental wall motion abnormality in the distal myocardial territory supplied by the graft; (3) new or worsening decline in left ventricular systolic function (LVEF decrease ≥ 10% from baseline); (4) intraoperative graft repositioning, re-anastomosis, or early postoperative interventional/surgical intervention due to ultrasound-indicated graft perfusion or functional abnormality. Any one of the above events constitutes this composite endpoint. | Intraoperative and up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Changes in Routine Hematology Parameters | Change from baseline over time in complete blood count parameters, including white blood cell count (×10⁹/L) and neutrophil percentage (%). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
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Inclusion criteria: 1. Age ≥18 years; 2. Definitive diagnosis of coronary atherosclerotic heart disease, with intention to undergo elective coronary artery bypass grafting (CABG) at this center; 3. Able to perform real-time ultrasound blood flow measurement before and after bypass grafting during the operation, and obtain relevant blood flow parameters of the left anterior descending artery, left circumflex artery, right coronary artery, and bypass graft; 4. The subject or his/her legal guardian provides informed consent and signs a written informed consent form.
Exclusion criteria: 1. Patients undergoing emergency surgery, rescue surgery, or unable to complete standardized measurements according to the study protocol; 2. Patients with significant preoperative hemodynamic instability requiring intra-aortic balloon counterpulsation, extracorporeal membrane oxygenation, or other mechanical circulatory support; 3. Patients requiring concomitant valve surgery, major vascular surgery, or other complex cardiac surgeries; 4. Patients scheduled for or undergoing sequential coronary artery bypass grafting; 5. Patients unable to complete effective echocardiographic measurements due to severe adhesion, poor anatomical conditions, limited surgical field exposure, or other technical reasons during the operation; 6. Patients with severe arrhythmias, severe cardiac dysfunction, or other conditions that may significantly affect the accuracy of intraoperative blood flow measurements; 7. Patients with severe preoperative liver, kidney, lung, or other vital organ failure that may significantly affect the evaluation of study endpoints; 8. Patients lacking key baseline data before surgery or expected to be unable to complete follow-up of primary endpoint indicators after surgery; 9. Pregnant or lactating women; 10. Other situations deemed unsuitable for inclusion in this study by the investigator.
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Definitive diagnosis of coronary atherosclerotic heart disease, with intention to undergo elective coronary artery bypass grafting (CABG) at this center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhikang Lv, MD | Contact | +8615258021027 | lvzhikang1996@163.com | |
| Qiang Wang, MD | Contact | +8615850573193 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| Longitudinal Changes in Inflammatory Biomarkers | Change from baseline over time in serum inflammatory markers, including C-reactive protein (CRP, mg/L), interleukin-6 (IL-6, pg/mL), and procalcitonin (PCT, ng/mL). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
| Longitudinal Changes in Coagulation and Platelet Function Parameters | Change from baseline over time in coagulation function, including prothrombin time (PT, seconds), activated partial thromboplastin time (aPTT, seconds), platelet count (×10⁹/L), and platelet function. Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
| Longitudinal Changes in Hepatic Function Parameters | Change from baseline over time in serum hepatic function markers, including alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), lactate dehydrogenase (LDH, U/L), total bilirubin (μmol/L), and direct bilirubin (μmol/L). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
| Longitudinal Changes in Renal Function Parameters | Change from baseline over time in serum renal function markers, including serum creatinine (μmol/L), uric acid (μmol/L), and estimated glomerular filtration rate (eGFR, mL/min/1.73m²). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
| Longitudinal Changes in Myocardial Injury and Cardiac Function Biomarkers | Change from baseline over time in serum myocardial injury and cardiac function markers, including high-sensitivity troponin T (hs-cTnT, ng/mL), B-type natriuretic peptide (BNP, pg/mL), creatine kinase (CK, U/L), and creatine kinase-MB isoenzyme (CK-MB, U/L). Blood samples will be collected at each time point and analyzed according to standardized laboratory procedures. | Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90 |
| Intraoperative and Perioperative Surgical Parameters and Complications | Intraoperative parameters including cardiopulmonary bypass time (minutes), aortic cross-clamp time (minutes), and total surgical time (minutes). Perioperative parameters including postoperative length of hospital stay (days), chest tube drainage volume (mL) and characteristics, postoperative blood transfusion requirement and volume (mL), and incidence of perioperative complications including sternal wound infection, secondary debridement, reintubation, pneumonia, and delirium. | Intraoperatively and during index hospital stay |
| Ultrasound-Derived Graft Flow Parameters and Diagnostic Accuracy | Intraoperative portable ultrasound parameters of distal graft perfusion and myocardial perfusion, including graft flow signals. These will be compared with postoperative conventional transthoracic echocardiography or other imaging modalities to evaluate the diagnostic accuracy and consistency of intraoperative ultrasound in assessing graft patency and distal perfusion status. | Intraoperative and at 30-day postoperative follow-up |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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