Coronary Plaque Morphology and Plaque Progression in Patients With Newly Diagnosed Type-2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Progression of contrast enhanced cardiac CT in relation to baseline and follow-up cardiovascular risk factors and biomarkers.
研究概览
简要总结
However, there is only very sparse information regarding the atherosclerotic burden and cardiovascular biomarkers in the early stages of type-2 diabetes, as the vast majority of studies have concerned diabetes populations with more than 5 years average diabetes age or high-risk subgroups, who at inclusion already had atherosclerotic disease manifestations.
Consequently, this study aims on evaluating the occurrence of early-stage subclinical atherosclerosis in newly diagnosed type-2 diabetes with special emphasis on coronary plaque characteristics by modern imaging techniques. These findings will be compared to the functional status of various peripheral arterial segments and biomarkers in the cross-sectional part of this study. The 5-year follow-up study intends to describe relationships between these selected measures for general atherosclerotic involvement and the progression of the coronary atherosclerotic burden by contemporary techniques.
详细描述
THE AIM
The objective of this study is to:
Study I: Compare the prevalence and complexity of coronary plaques in patients with newly discovered type-2 diabetes with a healthy control group matched for age and gender, as evaluated by coronary computed tomography angiography.
Study II: Describe the relationship between morphological, functional and biochemical estimates of arteriosclerosis in newly diagnosed type-2 diabetes.
Study III: Characterize the progression of coronary plaques in patients with newly discovered type-2 diabetes in a 5-year follow-up study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Newly diagnosed (< 1 year) diabetes patients clinically classified as type-2 diabetes patients of both sex.
- •Age 18 +.
排除标准
- •Type 1 diabetes (or have age<30 years and C-peptid<300pmol/l and GAD-ab titer> 20 IU/ml).
- •Renal insufficiency (GFR < 45 or se-creatinine >140 micromol/l).
- •Atrial fibrillation.
- •Life expectancy below 2 years.
- •Mental disease and/or misuse of alcohol or drugs that affects patient's ability to give informed consent.
- •Pregnancy at time of or planned at inclusion.
- •Patients with a history of prior atherothrombotic disease (including acute coronary syndromes, prior revascularization, ischemic stroke or peripheral arterial disease).
研究组 & 干预措施
Healthy
Patients in this cohort consist of 100 healthy patients
干预措施: Cardiac CT (Radiation)
Diabetes mellitus
Newly diagnosed (< 1 year) diabetes patients clinically classified as type-2 diabetes patients of both sex
干预措施: Cardiac CT (Radiation)
结局指标
主要结局
Progression of contrast enhanced cardiac CT in relation to baseline and follow-up cardiovascular risk factors and biomarkers.
时间窗: 5 years
Coronary artery calcification were quantified by non-contrast cardiac CT and were assessed by summing up the scores from all foci in the coronary arteries, expressed in Agatston units (U), using dedicated software (Syngo Calcium scoring, (Siemens Healthcare).
次要结局
- Biochemical analysis in relation to contrast enhanced cardiac CT(1 year)
- Body mass index (kg/m2)(1 year)
- Carotid intima media thickness(1 year)
- Ankle brachial index(1year)
- waist hip ratio (m)(1 year)
- Blood pressure (mmHg)(1 year)
研究者
Monija Mrgan
MD
Esbjerg Hospital - University Hospital of Southern Denmark