AI Model for Assessing Cardiac Surgeons' Techniques (CAMERA)

artifiCiAl Intelligence Model for Evaluating the Surgical Techniques of caRdiAc Surgeons (CAMERA)

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.

Study Overview

• Status: Recruiting
• Conditions: CABG; Cardiovascular Surgery; Surgeons; Artificial Intelligence (AI); CABG-patients

• Study Type: Observational
• Enrollment (Estimated): 284

Contacts and Locations

• Study Contact: Name: Lihua Zhang, M.D, Ph.D; Phone Number: 8613641359895; Email: zhanglihua@fuwai.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • FuWai Hospital, CAMS & PUMC
      • Contact: Xin Yuan, MD, PhD; Phone Number: 8601060866517; Email: yuanxinfuwai@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Consistency assessment between AI surgical evaluation scores and human expert scores.	At the end of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	AI surgical evaluation scores levels were divided into the following 3 score levels: low, middle, high; human expert scores levels were divided into the following 3 score levels: low, middle, high.	After enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Surgeon-level subgroup: age	Age subgroup is stratified into: <45, ≥45 years old	Baseline
Surgeon-level subgroup: sex	Sex subgroup is stratified into: female, male	Baseline
Surgeon-level subgroup: professional title	Professional title subgroup is stratified into: junior, associate, senior	Baseline
Surgeon-level subgroup: annual surgery volume	Annual surgery volume subgroup is stratified by tertiles	Baseline
Surgeon-level subgroup: total surgery volume	Total surgery volume subgroup is stratified by tertiles	Baseline
Surgeon-level subgroup: annual CABG volume	Annual CABG volume subgroup is stratified by tertiles	Baseline
Surgeon-level subgroup: total CABG volume	Total CABG volume subgroup is stratified by tertiles	Baseline
Patient-level subgroup: age	Age subgroup is stratified into: <65, ≥65 years old	Baseline
Patient-level subgroup: sex	Sex subgroup is stratified into: female, male	Baseline
Patient-level subgroup: the severity of coronary artery disease	The severity of coronary artery disease is measured by SYNTAX score and is stratified into: <23, 23-32, >32	Baseline

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-ZX070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No