Clinical trial NCT06739005: AI Model for Assessing Cardiac Surgeons' Techniques
Official title: ArtifiCiAl Intelligence Model for Evaluating the Surgical Techniques of CaRdiAc Surgeons (CAMERA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CABG-patients
CABG
Cardiovascular Surgery
Surgeons
Artificial Intelligence (AI)
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-12-18
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Consistency assessment between AI surgical evaluation scores and human expert scores.
timeFrame: At the end of enrollment
Secondary outcomes:
measure: Intraoperative measurement of graft flow and flow resistance.
timeFrame: After enrollment
measure: Characteristics of the surgeon's motion trajectory.
timeFrame: After enrollment
Other outcomes:
measure: Graft patency at 1 year postoperatively.
timeFrame: At 1 year
measure: Adverse cardiovascular events, such as myocardial infarction and stroke, within 6 months postoperatively.
timeFrame: At 6 months
measure: Adverse cardiovascular events, such as myocardial infarction and stroke, within 12 months postoperatively.
timeFrame: At 12 months
Locations:
Study officials:
References: