Intraoperative Portable Ultrasound for Real-Time Graft Perfusion Assessment During CABG: A Randomized Controlled Trial

NCT07700524 | Not Yet Recruiting

• 1 other identifier: NJGH-CABG-US2026
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Surgery; Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Longitudinal Changes in Routine Hematology Parameters

  Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90

• Longitudinal Changes in Inflammatory Biomarkers

  Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90

• Longitudinal Changes in Coagulation and Platelet Function Parameters

  Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90

• Longitudinal Changes in Hepatic Function Parameters

  Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90

• Longitudinal Changes in Renal Function Parameters

  Preoperatively, and at postoperative days 1, 2, 3, 7, 10, 30, and 90

Study Arms (2)

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.

Diagnostic Test: Intraoperative Portable Doppler Ultrasound

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.

Interventions

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.

Portable Ultrasound Real-time Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Definitive diagnosis of coronary atherosclerotic heart disease, with intention to undergo elective coronary artery bypass grafting (CABG) at this center

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Zhikang Lv, MD

CONTACT

+8615258021027; lvzhikang1996@163.com

Qiang Wang, MD

CONTACT

+8615850573193

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

CN (1)