- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07602634
Radiomics Features Predicting Outcomes of PAD (ROP)
Radiomics Features for Predicting Clinical Outcomes in Peripheral Artery Disease
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
-
-
-
Shanghai, Čína, 200040
- Huadong Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- aged between 18 and 100 years;
- meeting the diagnostic criteria for peripheral artery disease (PAD);
- successfully undergoing interventional surgery;
- successfully completing preoperative lower limb CTA or MRA examination with good image quality, suitable for radiomics analysis.
Exclusion Criteria:
- Heart failure (NYHA class III/IV);
- right-to-left shunt heart disease;
- severe aortic and mitral valve insufficiency;
- acute coronary syndrome, or malignant arrhythmia;
- severe pulmonary hypertension (pulmonary artery pressure >90mmHg);
- moderate to severe renal insufficiency (creatinine clearance rate <60ml/min);
- any allergic constitution;
- pregnancy and childbirth period;
- life expectancy <12 months;
- poor image quality, unable to analyze;
- incomplete medical history data;
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
patients of peripheral artery disease
patients of peripheral artery disease after intervention
|
non
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
major adverse limb events
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
all-cause death
Časové okno: From January 2015 to December 2025
|
death caused by any event
|
From January 2015 to December 2025
|
|
Major adverse cardiovascular events
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Jun Zhi Bao, Hospital Director, Huadong Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026K201
- 20260049 (Jiný identifikátor: Huadong Hospital)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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