Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SCORE2
研究概览
简要总结
This study aims to compare carotid intima-media thickness (CIMT) and layer-specific texture characteristics of the carotid wall between individuals with Type 2 diabetes mellitus (T2DM) and normoglycemic controls, to assess the impact of T2DM on these ultrasound variables and evaluate their ability to discriminate between low and high cardiovascular risk at 10 years.
详细描述
Cardiovascular disease (CVD) is the leading cause of death worldwide and accounts for approximately 45% of all deaths in Europe. Beyond mortality, CVD has a substantial impact on patients' quality of life and represents a significant economic burden on healthcare systems. T2DM is a key cardiovascular risk factor and an important determinant of serious cardiovascular complications, as it is associated with a worse prognosis after cardiac events and almost doubles the risk of all-cause mortality.
Primary prevention of CVD is a cornerstone of nursing practice, especially in the management of chronic diseases such as T2DM, where lifestyle interventions and long-term follow-up are essential. Several tools are available for the early detection of CVD, including cardiovascular risk (CVR) prediction models and imaging techniques. SCORE2 and SCORE2-Diabetes are widely used algorithms for estimating the 10-year risk of major cardiovascular events in European adults. Imaging modalities, such as carotid ultrasound, are becoming increasingly relevant, not only as diagnostic tools but also as support resources in nurse-led clinical assessment, as they provide objective and visual biomarkers of vascular health.
Carotid ultrasound allows for the assessment of established parameters related to CVR, such as CIMT, echogenicity, echovariation, and wall texture. Intima-media thickness (IMT) is a well-recognized marker of arterial injury and cardiovascular risk, especially in people with T2DM. While echogenicity and echovariation reflect tissue composition and structural heterogeneity, they may not detect early microstructural alterations. In contrast, texture features derived from gray-level co-occurrence matrix (GLCM) analyze spatial relationships between pixels, allowing the detection of subtle arterial changes associated with cardiovascular risk. Therefore, in nursing practice, layer-specific carotid texture analysis may offer a more accurate and personalized assessment of cardiovascular risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •European adults.
- •Age between 40 and 69 years.
- •Confirmed diagnosis of type 2 diabetes mellitus.
- •No established cardiovascular disease.
- •Availability of the required clinical and metabolic variables: Age; Sex; Systolic blood pressure; Non-high-density lipoprotein (non-HDL) cholesterol; Smoking status; Duration of diabetes; Glycated hemoglobin (HbA1c); Presence or absence of diabetes-related target organ damage (e.g., albuminuria, retinopathy)
排除标准
- •History of clinical cardiovascular disease (secondary prevention).
- •Type 1 diabetes mellitus.
- •Patients with established severe target organ damage or conditions that automatically classify them as very high cardiovascular risk according to ESC guidelines.
- •Advanced chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m²).
研究组 & 干预措施
Type 2 diabetes mellitus
干预措施: SCORE2-Diabetes (Diagnostic Test)
Type 2 diabetes mellitus
干预措施: Ultrasound Assessment (Diagnostic Test)
Healthy Subjects
干预措施: SCORE2 (Diagnostic Test)
Healthy Subjects
干预措施: Ultrasound Assessment (Diagnostic Test)
结局指标
主要结局
SCORE2
时间窗: baseline
* For participants aged 50-69 years: * Low-to-moderate risk: \<5% * High risk: ≥5% to \<10% * Very high risk: ≥10% * For participants aged 40-49 years: * Low-to-moderate risk: \<2.5% * High risk: ≥2.5% to \<7.5% * Very high risk: ≥7.5%
SCORE2 - Diabetes
时间窗: baseline
Low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%)
Energy or angular second moment (ASM)
时间窗: baseline
This measures the uniformity or regularity in the distribution of image values. Higher values indicate greater uniformity in the image
Homogeneity or inverse difference moment (IDM)
时间窗: baseline
This reflects the homogeneity of image composition, associated with pixel pairs. Homogeneous images with minimal variations produce high IDM valueS
Contrast (CON)
时间窗: baseline
Represents the degree of local variations in grey levels within the image. The greater the variation, the greater the contrast
Textural correlation (TCOR)
时间窗: baseline
Expresses linear dependencies between grey levels in the image. Regions with similar grey levels tend to exhibit higher values
Entropy (ENT)
时间窗: baseline
This indicates the level of disorder within the image. Homogeneous images result in lower entropy values
Carotid intima-media thickness (CIMT)
时间窗: baseline
(mm)
Echointensity
时间窗: baseline
The mean pixel intensity within an ultrasound region of interest (related to tissue brightness/echo)
Echovariation
时间窗: baseline
The variability or dispersion of pixel intensity within the ultrasound region of interest, corresponding to a measure of tissue heterogeneity
次要结局
未报告次要终点
研究者
SERGIO MONTERO NAVARRO
Clinical Professor
Cardenal Herrera University