Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCORE2, SCORE2-Diabetes, Ultrasound Assessment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus. Basic parameters: 40 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Carotid Wall Layer Texture as a Potential Biomarker for Cardiovascular Risk Assessment in Preventive Nursing: a Study in Type 2 Diabetes Mellitus
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test SCORE2
Will classify individuals into four cardiovascular risk categories: * 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% - Diagnostic test SCORE2-Diabetes
Will also classify individuals into four risk categories: low (\<5%), moderate (5-10%), high (10-20%), and very high (\>20%). - Diagnostic test Ultrasound Assessment
Three bilateral longitudinal scans of the common carotid artery will be obtained for carotid intima-media thickness (CIMT) measurement and stratification of carotid wall layers for subsequent texture analysis. Additionally, a bilateral video recording of the same imaging plane containing a minimum of five cardiac cycles will be acquired. One end-diastolic frame per video-corresponding to the relaxed arterial wall-will be selected to standardize image acquisition and CIMT measurement.
Primary outcome measures
- SCORE2 [Time frame: baseline]
- SCORE2 - Diabetes [Time frame: baseline]
- Energy or angular second moment (ASM) [Time frame: baseline]
- Homogeneity or inverse difference moment (IDM) [Time frame: baseline]
- Contrast (CON) [Time frame: baseline]
- Textural correlation (TCOR) [Time frame: baseline]
- Entropy (ENT) [Time frame: baseline]
- Carotid intima-media thickness (CIMT) [Time frame: baseline]
- Echointensity [Time frame: baseline]
- Echovariation [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Spain · 1 center
- Francisco Javier Molina Payá — Elche
Identifiers
NCT: NCT07373938 · CEEI24/547