Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 244
- 主要终点
- Coronary artery calcium score
研究概览
简要总结
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category.
Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events.
The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve <0.80 in any other major epicardial vessel) were enrolled.
Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required.
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS.
详细描述
Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice.
They will be, therefore, divided into two groups:
- Group A: subjects with T2DM with at least one DMC, as defined:
• Retinopathy, defined as any diabetes related eye disease (macular oedema, severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy) or previous history of retinal photocoagulation therapy and/or intravitreal injections of anti- vascular endothelial growth factor (VEGF) agents.
- Neuropathy, including any diabetes-related neurological complication (diabetic peripheral neuropathy, diabetic autonomic neuropathy).
- Nephropathy, defined as the presence of albuminuria (urinary albumin > 30 mg/g creatinine) and/or an estimated glomerular filtration rate < 60 mL/min/1.73 m2
- Group B: subjects with T2DM without DMCs.
Following data will be collected Anthropometric parameters
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed before any activity related to the study
- •Age 40 - 70 years, both sexes
- •Diagnosis of T2DM ≥5 years
- •CT coronary imaging performed in 60 days before enrollment
排除标准
- •Previous diagnosis of type 1 diabetes, late autoimmune diabetes of the adults (LADA), diabetes secondary to pancreatitis
- •Malignant disease
- •Acute/chronic inflammatory disease
- •Severe obesity
结局指标
主要结局
Coronary artery calcium score
时间窗: 24 months
Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications
次要结局
未报告次要终点