Coronary Artery Plaque Burden in Asymptomatic Danish Men Aged 65-75 Years and the Relation to Glycemic Status. A Coronary CT Angiography (CCTA) Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Correlation between glycemic status to coronary plaque burden and morphology.
研究概览
简要总结
Cardiovascular disease (CVD) is one of the leading causes of death in the Western Society. Patients with type 2 diabetes mellitus (T2DM) or dysglycemia have an increased risk of developing CVD. Furthermore, T2DM have an increased risk of developing heart failure, especially non-systolic, whether or not this is correlated to stepwise abnormal glycemic status is not fully investigated.
The aims of this study are to investigate association between 1) Coronary plaque burden and morphology to glycemic status (normal glucose tolerance (NGT), dysglycemia (impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)) and diabetic oral glucose tolerance test (OGTT) in participants without known T2DM), 2) Coronary plaque burden and morphology to diastolic and systolic function of the left ventricle including 2D speckle-tracking assessments, 3) Glycemic status to diastolic and systolic function of the left ventricle including 2D speckle-tracking assessments
In this descriptive study, 500-800 asymptomatic men aged 65-75 without known diabetes will be included and divided into three subpopulations according to glycemic status. Blood sample, oral glucose tolerance test (OGTT), echocardiography and Coronary CT Angiography (CCTA) will be performed at inclusion
详细描述
Background
Cardiovascular disease: Cardiovascular disease (CVD) is still one of the leading causes of death in the Western Society. Despite extensive research, risk estimation based on traditional risk factors predicts risk in the general population but may not give an adequate individual risk, and can thereby under- or overestimate the risk of future cardiovascular event and therefore lead to either over- or undertreatment of a not ignorable part of the population.
T2DM/dysglycemia and atherosclerosis: The prevalence of type 2 diabetes mellitus (T2DM) is rising rapidly. Furthermore, one study has reported that the prevalence of dysglycemia or undiagnosed diabetes were as high as 43.8% among 60-year-old men. T2DM is known to be strongly associated with an increased risk of CVD, but also dysglycemia has been associated with an increased risk of CVD. Thus, it is possible that there is a linear relationship between stepwise dysregulated glycemic status and increased coronary plaque burden, but the relationship has not been fully explored.
CCTA: Coronary CT Angiography (CCTA) can be performed with or without contrast. Contrast enhanced CCTA has been found to be a valid and reproducible method of evaluation of both extent and characteristics of atherosclerotic plaques. Motoyama et al. reported spotty calcification, positive remodeling, and LAP (non-calcified plaque) to be associated with an increased risk of development of AMI, especially when two or more patterns were co-localized in the plaques. Thus, it might be possible that this type of plaque morphology is associated with vulnerable plaques.
Echocardiography and T2DM/Dysglycemia: T2DM is correlated to a higher incidence of diastolic dysfunction, which is thought to predispose to diabetic cardiomyopathy. In addition, subtle left ventricular systolic dysfunction assessed by 2D speckle-tracking (also termed impaired strain) was found in patients with diabetes and normal systolic function. To our knowledge only few studies have investigated diastolic dysfunction and 2D speckle-tracking in patients with dysglycemia and their results were mostly diverging.
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
- 65 Years 至 75 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •65-75 years
- •Capable of giving written informed consent
- •Participates in the DANCAVAS study
排除标准
- •Body mass index (BMI) >35
- •Atrial fibrillation and other tachyarrhythmia that unable CCTA analysis
- •Estimates Glomerular filtration rate (eGFR) <45 ml/min
- •Contrast allergy
- •Untreated hyperthyroid
- •History of CAD or Apoplexia
- •Symptoms of CAD
- •Known Diabetes Mellitus
结局指标
主要结局
Correlation between glycemic status to coronary plaque burden and morphology.
时间窗: Baseline
To evaluate the correlation between glycemic status (NGT, dysglycemia or Diabetic OGTT in patients without known T2DM) to plaque burden and morphology in asymptomatic men, aged 65-75 years. Plaque burden analyzed per vessel is defined as either percent atheroma volume (PAV), total atheroma volume (TAV) or normalized atheroma volume (NAV). Plaque morphology will include per plaque analysis of LAP (noncalcified plaque), remodeling indices (RI), spotty calcification and degree of stenosis where a significant stenosis is defined as \>70 % of the luminal area. Above mentioned definitions of plaque burden and morphology is further explained in detail in Study Description above.
次要结局
- Association between coronary artery plaque burden and morphology to diastolic and systolic function of the left ventricle.(Baseline)
- Association between glycemic status to diastolic and systolic function of the left ventricle.(Baseline)
研究者
Johanna Larsson
Johanna Larsson, Svendborg Hospital
Svendborg Hospital