AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection

January 28, 2026 updated by: Hong Liu, Nanjing Medical University

AI-assisted Immunoinflammatory Subtyping-Directed Precision Treatment in Acute Aortic Dissection: A Multicenter RCT-based Exploration

Aortic dissection has acute onset and high mortality, with immunoinflammatory response driving lesion progression. Current perioperative anti-inflammatory therapies are mostly empirical and poorly targeted, and AI-assisted typing lacks a complete clinical translation pathway. This study integrates multi-dimensional data to construct an AI immunoinflammatory subtyping system, enabling rapid subtyping and establishing a "subtyping-target-treatment" closed loop for emergency needs. Using a prospective multicenter RCT, 300 patients are randomly divided into two groups: the experimental group receives subtyping-based precision therapy, while the control group uses empirical strategies (treatment of physician's choice). It observes 7-day postoperative SOFA score, SIRS and other prognostic indicators to provide evidence-based support for precision treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Beijing Anzhen Hospital
        • Contact:
          • Hai-yang Li
        • Contact:
        • Principal Investigator:
          • Hong-jia Zhang, MD
      • Changzhou, China
        • Changzhou First People Hospital
        • Contact:
        • Contact:
          • Chao Ma, MD
        • Principal Investigator:
          • Chao Ma, MD
      • Chengdu, China
        • West China Hospital of Sichuan University
        • Contact:
          • Zhong Wu, MD
        • Contact:
        • Principal Investigator:
          • Hong-hua Yue, MD
      • Fuzhou, China
        • Fujian Medical University Union Hospital
        • Contact:
        • Contact:
          • Dong-dong Wu, MD
        • Principal Investigator:
          • Dong-dong Wu, MD
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • KAI WANG
        • Contact:
        • Principal Investigator:
          • Ying-yuan Zhang, MD
      • Nanchang, China
        • Nanchang University Second Hospital
        • Contact:
        • Contact:
          • Ji-sheng Zhong, MD
        • Principal Investigator:
          • JI-SHENG Zhong, MD
      • Nanjing, China
        • The First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Hong Liu, MD
        • Contact:
        • Contact:
          • Yong-feng Shao
      • Shanghai, China
        • Shanghai East Hospital
        • Principal Investigator:
          • Guo-liang Fan, MD
        • Contact:
        • Contact:
          • Hai-tao Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of acute aortic dissection by contrast-enhanced Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA);
  2. Planned emergency surgical treatment (including open surgery and endovascular repair);
  3. Aged 18-80 years old, regardless of gender;
  4. Time from onset to hospital admission ≤ 72 hours;
  5. Signed informed consent form by the patient or their authorized agent, with willingness to cooperate with the follow-up of the study.

Exclusion Criteria:

  1. Complicated with underlying diseases that affect immunoinflammatory status, such as severe infections (e.g., sepsis, infective endocarditis), autoimmune diseases, malignant tumors, chronic liver diseases, and chronic kidney diseases (uremic stage);
  2. Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
  3. Pregnant or lactating women;
  4. Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subtyping-based precision therapy

  • Balanced type (HIS1): No anti-inflammatory intervention required;

    • Inflammation-excessive type (HIS2): Anti-inflammatory intervention with ulinastatin; ③ Immunosuppressive type (HIS3): Immunomodulation with thymalfasin; ④ Mixed reaction type (HIS4): Combined treatment with ulinastatin and thymalfasin.
Drug: Ulinastatin and Thymalfasin
AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy
Active Comparator: Conventional Empirical Strategy
treatment of physician's choice alone
Drug: Ulinastatin
Conventional empirical regimens will be formulated based on patients' clinical symptoms and routine inflammatory indicators (white blood cell count, C-reactive protein, procalcitonin) without uniform target-matching standards, with reference to clinical diagnosis and treatment guidelines: if obvious inflammatory responses are present (e.g., fever, significant elevation of C-reactive protein), non-steroidal anti-inflammatory drugs or low-dose glucocorticoids will be administered; if complicated with infection, combined antibiotic therapy will be given; for patients with normal or slightly elevated inflammatory indicators, anti-inflammatory drugs may be temporarily withheld, and close monitoring will be performed instead. The regimen will be adjusted according to changes in routine inflammatory indicators after surgery until the patient is discharged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Organ Failure Assessment (SOFA) score. The SOFA score evaluates 6 organ systems, ranging from 0, no dysfunction, to 4, failure, and the total score ranges from 0, normal, to 24, most severe form of multiorgan failure.
Time Frame: 7 days after surgery
The SOFA score evaluates 6 organ systems, ranging from 0, no dysfunction, to 4, failure, and the total score ranges from 0, normal, to 24, most severe form of multiorgan failure.
7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Beijing Anzhen Hospital
Shanghai East Hospital
Fujian Medical University Union Hospital
Second Affiliated Hospital of Nanchang University
Third Affiliated Hospital of Soochow University

Investigators

  • Study Director: Yong-feng Shao, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Hong Liu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2027

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA-Smart

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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