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NCT Number: NCT07382375

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Ulinastatin and Thymalfasin

Drug

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

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo-laing Fan, MD

CONTACT

[email protected]

Sheng Zhao

CONTACT

[email protected]

18801281613

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2027
Primary completion: 2027
Study completion: 2027
First posted: Feb 2, 2026
Registry last updated: Feb 2, 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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