Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG

NCT07700524 | Not Yet Recruiting

• 2 other identifiers: NJGH-CABG-US202612274220
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Intraoperative ultrasound; Coronary artery bypass grafting; Native coronary artery blood flow; Bypass graft blood flow; Transit-time flow measurement; Feasibility; Safety; Prospective cohort study

Outcome Measures

Primary Outcomes (2)

• Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment

  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.

  During the coronary artery bypass grafting procedure

• Incidence of Adverse Events Related to the Intraoperative Ultrasound Device or Measurement Procedure

  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.

  From the first intraoperative ultrasound measurement to 30 ± 7 days after surgery

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Diagnostic Test: Intraoperative Ultrasound Blood Flow Measurement

Interventions

Intraoperative Ultrasound Blood Flow Measurement DIAGNOSTIC_TEST

Intraoperative ultrasound measurements of major native coronary arteries will be obtained before and after revascularisation, followed by measurements of individual bypass grafts after restoration of blood flow. Recorded variables will include blood flow velocity, volumetric blood flow and other protocol-defined quantitative parameters. The findings will be collected for research purposes and will not guide graft revision or other intraoperative clinical decisions.

Intraoperative Ultrasound CABG Cohort

Eligibility Criteria

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

Study Population

The study population will consist of adults undergoing elective isolated coronary artery bypass grafting in the Department of Cardiac Surgery at Nanjing Drum Tower Hospital. Consecutive patients meeting the eligibility criteria will be screened and enrolled after providing written informed consent.

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Study Officials

• Qiang Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhikang Lv, MD

CONTACT

+8615258021027; lvzhikang1996@163.com

Qiang Wang, MD

CONTACT

+8615850573193; njuwangqiang@163.com

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 (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-07

Locations

CN (1)