Evaluating Pericoronary Adipose Tissue Attenuation in Glycometabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 747
- 试验地点
- 1
- 主要终点
- PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography
研究概览
简要总结
In this study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with and without type 2 diabetes who have no heart symptoms have been examined and had a CCTA scan performed.
This study aims to answer the following questions:
• Is inflammation in the surrounding fat tissue of the heart arteries associated with the following glycometabolic conditions: I) Obesity ii) Prediabetes iii) Type 2 diabetes
详细描述
Background and significance:
Inflammation in the coronary arteries is a key driver of cardiovascular (CV) disease, particularly in individuals with glycometabolic conditions such as obesity and diabetes. However, traditional biomarkers have limited accuracy in detecting coronary inflammation.
Coronary CT angiography (CCTA) allows for the non-invasive measurement of pericoronary adipose tissue (PCAT) attenuation - the fat surrounding coronary arteries. PCAT and the underlying vessels engage in bidirectional communication, and inflammation alters the structure of PCAT, which can be detected by CCTA.
Glycometabolic diseases promote atherosclerosis through endothelial dysfunction and accumulation of inflammatory cells. Obesity and diabetes are both associated with enlarged adipocytes, which may influence PCAT attenuation by lowering its Hounsfield Unit values, potentially masking underlying inflammation. To date, no studies have thoroughly addressed the possibility that PCAT attenuation may be underestimated in this high-risk CV population.
The PCAT-GMD study is a post-hoc analysis of two trials - CARPE-DM (NCT03016910) and DANCAP (NCT04525508) - aiming to evaluate the relationship between PCAT attenuation and the following glycometabolic conditions:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Above 18 years
- •Capable of giving written informed consent
排除标准
- •History of CAD
- •Symtoms of CAD (angina)
- •Any tachyarrhythmias making CCTA impossible
- •Estimated glomerular filtration rate (eGFR) under 45 ml/min
- •Allergy to iodine contrast
- •Critical illness with life expectancy less than 1 year
- •Documented heart failure
结局指标
主要结局
PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography
时间窗: Baseline
PCAT attenuation \[HU\] will be assessed for correlation with the following variables: * BMI \[kg/m²\] \[Continously, and categorized as normal (ref), overweight, obesity class 1, obesity class 2+\]. * Prediabetes, defined as HbA1c: 39-47 mmol/mol \[Categorical: no(ref)/yes\]. * Type 2 diabetes mellitus, defined by WHO criteria \[Categorical: no(ref)/yes\].
次要结局
- PCAT Attenuation [HU] measured by coronary CT angiography(Baseline)
研究者
Katrine Schultz Overgaard
Dr. Med.
Odense University Hospital