AI Model for Assessing Cardiac Surgeons' Techniques

NCT06739005 | Recruiting

• 1 other identifier: 2024-ZX070
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study aims to investigate the use of artificial intelligence to analyze and evaluate the characteristics and proficiency of surgeons during vascular anastomosis in coronary artery bypass grafting (CABG) procedures. The main question it aims to answer is: Consistency assessment between AI evaluation scores and human expert evaluation scores for surgeons during left anterior descending (LAD) artery anastomosis.

Conditions

CABG-patients; CABG; Cardiovascular Surgery; Surgeons; Artificial Intelligence (AI)

Outcome Measures

Primary Outcomes (1)

• Consistency assessment between AI surgical evaluation scores and human expert scores.

  At the end of enrollment

Secondary Outcomes (3)

• Intraoperative measurement of graft flow and flow resistance.

  After enrollment

• Characteristics of the surgeon's motion trajectory.

  After enrollment

• Consistency assessment between AI surgical evaluation scores levels and human expert scores levels.

  After enrollment

Other Outcomes (13)

• Graft patency at 1 year postoperatively.

  At 1 year

• Adverse cardiovascular events, such as myocardial infarction and stroke, within 6 months postoperatively.

  At 6 months

• Adverse cardiovascular events, such as myocardial infarction and stroke, within 12 months postoperatively.

  At 12 months

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 consists of adult patients who meet the inclusion criteria of being aged 18 years or older, undergoing their first isolated coronary artery bypass grafting (CABG) surgery using internal mammary artery-to-left anterior descending artery bypass grafting. All participants should signed written informed consent prior to inclusion in the study. Exclusion criteria include patients with acute coronary syndrome, contraindications to coronary CT angiography or coronary angiography, and those with renal insufficiency or active liver disease. Specifically, patients with persistently elevated serum transaminases of unknown cause or those with any serum transaminase levels exceeding three times the upper limit of normal will also be excluded from the study.

You may qualify if:

• Age ≥ 18 years
• Undergoing internal mammary artery-to-left anterior descending artery bypass grafting
• First-time recipient of isolated CABG surgery
• Signed written informed consent

You may not qualify if:

• Patients with acute coronary syndrome
• Patients with contraindications to coronary CT angiography or coronary angiography
• Patients with renal insufficiency or active liver disease, including those with persistently elevated serum transaminases of unknown cause or any serum transaminase levels exceeding three times the upper limit of normal.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100037, China

RECRUITING

Central Study Contacts

Lihua Zhang, M.D, Ph.D

CONTACT

8613641359895; zhanglihua@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician of Chinese Academy of Engineering President, Fuwai Hospital Director, National Center for Cardiovascular Diseases Director, NCRC Director, State Key Laboratory of Cardiovascular Disease Chairman, China Heart Congress (CHC) Former President

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CN (1)