AI-assisted Immunoinflammatory Subtyping-Directed Precision Treatment in Acute Aortic Dissection: A Multicenter RCT-based Exploration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ulinastatin and Thymalfasin (Drug)
Conventional Empirical Strategy
treatment of physician's choice alone
干预措施: Ulinastatin (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University