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NCT Number: NCT07539532

Comparing Traditional Risk Scores and an AI-Based Multimodal Model for Predicting Cardiovascular Events After Gastrointestinal Surgery

The goal of this observational study is to develop and evaluate an artificial intelligence (AI)-based multimodal model for predicting major cardiovascular events within 30 days after gastrointestinal surgery in adults at Bach Mai Hospital. The study will also compare the predictive performance of this AI-based model with commonly used traditional risk scores.

The main questions it aims to answer are:

Can an AI-based multimodal model predict major cardiovascular events within 30 days after gastrointestinal surgery? Does the AI-based model show better predictive performance than the Revised Cardiac Risk Index (RCRI), the American College of Surgeons National Surgical Quality Improvement Program Myocardial Infarction or Cardiac Arrest calculator (ACS NSQIP MICA), and the ACS NSQIP Surgical Risk Calculator (ACS NSQIP SRC)? Researchers will compare the AI-based multimodal model with traditional risk scores using measures of predictive performance, including discrimination, calibration, net reclassification improvement, and integrated discrimination improvement.

Participants will be adults undergoing gastrointestinal surgery. Researchers will review medical record data from patients treated in 2025 and will also collect the same types of clinical data prospectively in 2026. The clinical outcome being predicted is the occurrence of major cardiovascular events within 30 days after surgery. The study will not change routine clinical care.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bach Mai hospital

Hà Nội, Vietnam

Location status: Recruiting

Location contact

Nguyen Toan Thang, Thang

CONTACT

[email protected]

PhD, MD

About this study

Major cardiovascular events after gastrointestinal surgery remain an important cause of early postoperative complications and poor outcomes. Traditional perioperative cardiac risk scores, including the Revised Cardiac Risk Index (RCRI), the American College of Surgeons National Surgical Quality Improvement Program Myocardial Infarction or Cardiac Arrest calculator (ACS NSQIP MICA), and the ACS NSQIP Surgical Risk Calculator (ACS NSQIP SRC), are widely used in clinical practice. However, their performance may be limited in specific surgical populations and may not fully capture complex interactions among clinical, laboratory, physiologic, and procedural variables.

This observational study aims to develop and evaluate an artificial intelligence (AI)-based multimodal model for predicting major cardiovascular events within 30 days after gastrointestinal surgery and to compare its predictive performance with traditional risk scores. The study will be conducted at Bach Mai Hospital and will include adult patients undergoing gastrointestinal surgery. The study uses a mixed retrospective-prospective design, with retrospective data collection from patients treated in 2025 and prospective data collection in 2026.

The target clinical outcome for prediction is the occurrence of major cardiovascular events within 30 days after surgery. These events include cardiovascular death, nonfatal myocardial infarction, cardiac arrest with return of spontaneous circulation, new stroke, and clinically significant arrhythmias requiring treatment. Data used for model development and comparison may include demographic characteristics, medical history, cardiovascular comorbidities, surgical characteristics, anesthetic information, preoperative laboratory results, electrocardiographic findings, biomarkers when available, and functional or risk assessment variables.

The primary outcome of the study is the discrimination performance of the AI-based multimodal model compared with traditional risk scores, measured by the area under the receiver operating characteristic curve for predicting 30-day major cardiovascular events after gastrointestinal surgery. Secondary outcomes include calibration performance, net reclassification improvement, and integrated discrimination improvement of the AI-based multimodal model compared with traditional risk scores, including RCRI, ACS NSQIP MICA, and ACS NSQIP SRC.

The study is observational and will not alter routine perioperative management. Data will be obtained from existing medical records and prospective clinical collection, coded for confidentiality, and analyzed to support risk stratification and model comparison in patients undergoing gastrointestinal surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Undergoing gastrointestinal surgery at Bach Mai Hospital between January 2025 and December 2026.
  • Available preoperative, intraoperative, and postoperative data sufficient for analysis.

Exclusion criteria

  • Death within 24 hours after surgery due to a clearly non-cardiovascular cause.
  • Incomplete data required for analysis.

Treatment and study plan

Primary outcomes

  1. Area under the receiver operating characteristic curve of the AI-based multimodal model for predicting 30-day major adverse cardiovascular events after gastrointestinal surgery

    Time frame: From the preoperative period to 30 days after surgery.

    Discrimination performance of the AI-based multimodal model for predicting 30-day major adverse cardiovascular events after gastrointestinal surgery.

Secondary outcomes

  1. Brier score of the AI-based multimodal model for predicting 30-day major cardiovascular events after gastrointestinal surgery

    Time frame: From the preoperative period to 30 days after surgery

    Overall prediction accuracy of the AI-based multimodal model as assessed by the Brier score. Lower values indicate better model performance.

  2. Net Reclassification Improvement of the AI-Based Multimodal Model Compared With Traditional Risk Scores for Predicting 30-Day Major Cardiovascular Events After Gastrointestinal Surgery

    Time frame: Using perioperative data collected from the preoperative period through 30 days after surgery

    Net reclassification improvement of the AI-based multimodal model compared with traditional risk scores for prediction of major cardiovascular events within 30 days after gastrointestinal surgery.

  3. Integrated Discrimination Improvement of the AI-Based Multimodal Model Compared With Traditional Risk Scores for Predicting 30-Day Major Cardiovascular Events After Gastrointestinal Surgery

    Time frame: Using perioperative data collected from the preoperative period through 30 days after surgery

    Integrated discrimination improvement of the AI-based multimodal model compared with traditional risk scores for prediction of major cardiovascular events within 30 days after gastrointestinal surgery.

  4. Area under the receiver operating characteristic curve of the Revised Cardiac Risk Index for predicting 30-day major cardiovascular events after gastrointestinal surgery

    Time frame: From the preoperative period to 30 days after surgery

    Discrimination performance of the Revised Cardiac Risk Index.

  5. Area under the receiver operating characteristic curve of the ACS NSQIP Surgical Risk Calculator for predicting 30-day major cardiovascular events after gastrointestinal surgery

    Time frame: From the preoperative period to 30 days after surgery

    Discrimination performance of the ACS NSQIP Surgical Risk Calculator.

  6. Calibration slope of the AI-based multimodal model for predicting 30-day major cardiovascular events after gastrointestinal surgery

    Time frame: From the preoperative period to 30 days after surgery

    Agreement between predicted and observed risk as assessed by the calibration slope. A value closer to 1 indicates better calibration.

Sponsors and collaborators

Lead sponsor

Bach Mai Hospital

Other

Registry information

Official study title

Value of Some Risk Scores in Predicting Cardiovascular Events After Gastrointestinal Surgery

Acronym: GI-MACE-AI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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