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Radiomics Features Predicting Outcomes of PAD (ROP)

2026年5月16日 更新者:Zhijun Bao

Radiomics Features for Predicting Clinical Outcomes in Peripheral Artery Disease

There is a high risk of restenosis and vascular occlusion after interventional treatment for peripheral arterial disease (PAD), and some severe patients inevitably end up with amputation. Perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ, which could provide a new imaging perspective into the pathophysiological mechanism of lower limb atherosclerosis microenvironment. The aim of this study is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after interventional treatment. The study aims to offer clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.

研究概览

地位

主动,不招人

详细说明

After interventional treatment for peripheral arterial disease (PAD), there is a high risk of restenosis and vascular occlusion, and some severe patients inevitably end up with amputation. Currently, in clinical practice, preoperative CTA is often relied upon to assess the degree of luminal stenosis and wall calcification burden in order to develop surgical strategies and predict prognosis. However, these traditional macroscopic indicators often cannot fully reflect the microscopic inflammatory state of the vascular wall and plaque instability, resulting in limited predictive power for postoperative clinical outcomes.

In recent years, perivascular adipose tissue (PVAT) has been recognized not only as an inert tissue providing mechanical support, but also as a highly active endocrine and paracrine organ. In the early stage of atherosclerosis, the inflammatory signal of vascular wall can be transmitted from the inside out to PVAT, causing changes in its phenotype and local lipid metabolism. At present, breakthrough progress has been made in imaging research on PVAT both domestically and internationally, but the vast majority of studies focus on coronary arteries, carotid arteries, and aorta. For example, based on the conventional coronary CTA extraction of the Pericoronal Fat Attenuation Index (FAI) and radiomics features, it has been proven by multiple high-quality studies to effectively identify vulnerable plaques and independently predict adverse cardiovascular events. However, imaging research on peripheral arterial PVAT in the lower limbs is still in a blank state both domestically and internationally. There are significant differences in hemodynamics, anatomical structure, and risk factors between lower limb arteries and coronary and carotid arteries. It is urgent to explore whether the imaging phenotype changes of lower limb PVAT can also serve as a detector for evaluating local vascular lesions.

This project is the first to shift the focus to the peripheral arteries of the lower limbs. By introducing high-throughput radiomics techniques, non-invasive and quantitative extraction of three-dimensional spatial texture and grayscale heterogeneity features of lower limb PVAT that cannot be recognized by the naked eye is performed from routine preoperative lower limb vascular enhancement images (CTA or MRA) of patients. This not only expands the disease research spectrum of PVAT, but also provides a new imaging perspective for in-depth understanding of the pathophysiological mechanism of lower limb atherosclerosis microenvironment.

This study is based on real clinical application scenarios and does not require patients to bear additional radiation risks or examination costs. The aim of this project is to identify novel and reliable non-invasive imaging biomarkers by exploring the potential association between lower limb PVAT imaging omics features and clinical outcomes (including death, major amputation, target vessel revascularization, etc.) in patients with PAD after intracavitary treatment. This is expected to break the limitations of traditional lumen stenosis and calcification assessment, providing clinicians with more accurate personalized risk stratification tools before surgery, thereby optimizing clinical decision-making and helping to achieve precision medicine for PAD.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Shanghai、中国、200040
        • Huadong Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

patients of peripheral artery disease after intervention

描述

Inclusion Criteria:

  1. aged between 18 and 100 years;
  2. meeting the diagnostic criteria for peripheral artery disease (PAD);
  3. successfully undergoing interventional surgery;
  4. successfully completing preoperative lower limb CTA or MRA examination with good image quality, suitable for radiomics analysis.

Exclusion Criteria:

  1. Heart failure (NYHA class III/IV);
  2. right-to-left shunt heart disease;
  3. severe aortic and mitral valve insufficiency;
  4. acute coronary syndrome, or malignant arrhythmia;
  5. severe pulmonary hypertension (pulmonary artery pressure >90mmHg);
  6. moderate to severe renal insufficiency (creatinine clearance rate <60ml/min);
  7. any allergic constitution;
  8. pregnancy and childbirth period;
  9. life expectancy <12 months;
  10. poor image quality, unable to analyze;
  11. incomplete medical history data;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
patients of peripheral artery disease
patients of peripheral artery disease after intervention
non

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
major adverse limb events
大体时间:From January 2015 to December 2025
severe adverse clinical events occurring in the limbs, such as target-limb re-intervention, acute limb ischemia, amputation, etc.
From January 2015 to December 2025

次要结果测量

结果测量
措施说明
大体时间
all-cause death
大体时间:From January 2015 to December 2025
death caused by any event
From January 2015 to December 2025
Major adverse cardiovascular events
大体时间:From January 2015 to December 2025
severe cardiovascular-related adverse events, typically including myocardial infarction (heart attack), stroke, cardiovascular death, etc,
From January 2015 to December 2025

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Jun Zhi Bao, Hospital Director、Huadong Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026K201
  • 20260049 (其他标识符:Huadong Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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