Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Changes in plaque morphology stratified by cardiovascular risk factors.
研究概览
简要总结
Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction and additional risk factors on plaque morphology and plaque burden in patients with diabetes mellitus.
详细描述
Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as patients with a prior (MI) without diabetes. In addition to macrovascular complications, and traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting several organs. The dynamics between microvascular dysfunction, known cardiac risk factors and coronary atherosclerosis in diabetic disease is not well characterized.
In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type 1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in diabetes will be compared to a historical cohort of patients with acute myocardial infarction (AMI).
All study participant will undergo the following examinations at baseline:
- CCTA
- CAC-score
- Transthoracic echocardiography
- 12-lead ECG
- Blood pressure and pulse frequency
- Height, weight, waist to hip-ratio
- Blood samples and urin samples
- Medical history
After 12 months all of the above examinations will be repeated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Type 1 or 2 diabetes mellitus
- •Ability to provide informed conscent
排除标准
- •History of CAD
- •Symtoms of CAD (angina)
- •Any tachyarrhythmias making CCTA impossible
- •Glumerular filtration rate (GFR)< 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
Changes in plaque morphology stratified by cardiovascular risk factors.
时间窗: Baseline,12 months
Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Changes in plaque burden stratified by cardiovascular risk factors
时间窗: Baseline, 12 months
Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
Changes in plaque burden stratified by diabetic complications.
时间窗: Baseline,12 months.
Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
Changes in plaque morphology stratified by diabetic complications
时间窗: Baseline, 12 months
Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.
次要结局
- Changes in plaque burden in diabetes compared to AMI-patients without diabetes.(Baseline and 12 months)
- Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.(Baseline,12-months)
- Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.(Baseline,12-months)
- Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.(Baseline,12-months)
- Impact of asymtomatic CAD in diabetes on future events.(5-7 years)
研究者
Laurits Heinsen
Medical doctor
Svendborg Hospital