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

NCT07382375 | Not Yet Recruiting

• 1 other identifier: PANDA-Smart
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Aortic Aneurysm and Dissection

Keywords

inflammation; immune

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (2)

Subtyping-based precision therapy

EXPERIMENTAL

* 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

Conventional Empirical Strategy

ACTIVE COMPARATOR

treatment of physician's choice alone

Drug: Ulinastatin

Interventions

Ulinastatin DRUG

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.

Conventional Empirical Strategy

Ulinastatin and Thymalfasin DRUG

AI-assisted Immunoinflammatory Subtyping-guided Target-matching Individualized Anti-inflammatory Strategy

Subtyping-based precision therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);
• Long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);
• Pregnant or lactating women;
• Patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.

Sponsors & Collaborators

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

Study Sites (8)

Beijing Anzhen Hospital

Beijing, China

Location

Changzhou First People Hospital

Changzhou, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Nanchang University Second Hospital

Nanchang, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

Shanghai East Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Aortic Dissection; Inflammation

Interventions

urinastatin; Thymalfasin

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Yong-feng Shao

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• Hong Liu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Zhao

CONTACT

18801281613; zhaosheng0824@njmu.edu.cn

Guo-laing Fan, MD

CONTACT

smartmanliang@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 2, 2026
• Study Start (Estimated): December 31, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)