Coronary Artery DiseaseNCT07700524
Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG
An observational study of Coronary Artery Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intraoperative Ultrasound Blood Flow Measurement
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Zhikang Lv, MD, +8615258021027, lvzhikang1996@163.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Intraoperative Ultrasound Blood Flow Measurement
- 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
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Ultrasound Blood Flow MeasurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intraoperative Ultrasound Blood Flow Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the first intraoperative ultrasound measurement to 30 ± 7 days after surgery
Secondary outcomes (4)
Agreement Between Intraoperative Ultrasound and Transit-Time Flow Measurements
Agreement between comparable bypass graft blood flow parameters obtained using intraoperative ultrasound and transit-time flow measurement will be evaluated in grafts with analysable paired measurements using intraclass correlation coefficients and Bland-Altman analysis.
Measured: 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
Volumetric blood flow will be measured in the same analysable segments of the left anterior descending, left circumflex, and right coronary arteries immediately before revascularisation and after completion of graft anastomoses following haemodynamic stabilisation. For each analysable native coronary artery, the within-vessel change will be calculated as post-revascularisation volumetric blood flow minus pre-revascularisation volumetric blood flow. The native coronary artery will be the unit of analysis, and the mean of all analysable vessel-level change values will be reported in mL/min. Positive values indicate increased blood flow after revascularisation.
Measured: During CABG: immediately before revascularisation and after completion of graft anastomoses following haemodynamic stabilisation
Repeatability of Intraoperative Ultrasound Blood Flow Measurements
Repeatability of intraoperative ultrasound-derived quantitative blood flow parameters will be evaluated using repeated measurements obtained at the same vascular measurement site. Intraclass correlation coefficients, coefficients of variation, repeatability coefficients, and Bland-Altman limits of agreement will be calculated.
Measured: During the coronary artery bypass grafting procedure
Association of Intraoperative Blood Flow Parameters With Postoperative Cardiac Function and Myocardial Injury Biomarkers
Associations between intraoperative ultrasound-derived native coronary artery and bypass graft blood flow parameters and postoperative measures of cardiac function, cardiac structure, and myocardial injury will be explored. Planned measures include left ventricular ejection fraction, left ventricular end-diastolic diameter, B-type natriuretic peptide or N-terminal pro-B-type natriuretic peptide, cardiac troponin T or cardiac troponin I, and other protocol-defined measures.
Measured: From the preoperative baseline assessment to 30 ± 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, MD, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700524
- Sponsor's protocol ID
- NJGH-CABG-US2026
- Other IDs
- 12274220
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07700524
- Acronym / sponsor ID
- NJGH-CABG-US2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Ultrasound CABG Cohort | – | Diagnostic Test: Intraoperative Ultrasound Blood Flow MeasurementThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Ultrasound Blood Flow MeasurementIntraoperative 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. | Diagnostic test | Intraoperative Ultrasound CABG Cohort |
Primary outcome
Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment
Time frame: 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
Time frame: 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.
4 secondary outcomes
Agreement Between Intraoperative Ultrasound and Transit-Time Flow Measurements
Time frame: 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
Time frame: During CABG: immediately before revascularisation and after completion of graft anastomoses following haemodynamic stabilisation
Repeatability of Intraoperative Ultrasound Blood Flow Measurements
Time frame: During the coronary artery bypass grafting procedure
Association of Intraoperative Blood Flow Parameters With Postoperative Cardiac Function and Myocardial Injury Biomarkers
Time frame: From the preoperative baseline assessment to 30 ± 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Wang, MD principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhikang Lv, MD (+8615258021027, lvzhikang1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-Level Technical Success Rate of the Protocol-Defined Intraoperative Ultrasound Assessment (time frame: During the coronary artery bypass grafting procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.