Prospective Associations of Pericoronary Adipose Tissue Computed Tomography Attenuation With Coronary Plaque Features and Major Adverse Cardiovascular Events in a Population With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Baseline PCAT attenuation and plaque features at the 12-month CCTA
研究概览
简要总结
In this prospective 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 type 2 diabetes who have no heart symptoms have been examined, using a CCTA at the start of the study and again after 12 months.
This study aims to answer the following questions:
- Can inflammation in the surrounding fat tissue at the baseline CCTA predict the amount and type of plaque, and the presence of harmful plaque characteristics present after 12 months? (paper 1)
- Do changes in inflammation in the surrounding fat tissue from baseline to the 12 months CCTA correlate with the amount and type of plaque and the presence of harmful plaque characteristics at the 12 months CCTA? (paper 1)
- Is inflammation in the surrounding fat tissue a predictor for the development of cardiovascular events after a follow-up period of 7 years? (paper 2)
- Do changes in inflammation in the surrounding fat tissue after 12 months predict the later development of cardiovascular events after a follow-up period of 7 years? (paper 2)
详细描述
Background and significance:
Inflammation in the coronary arteries plays a significant role in the development of heart disease, particularly in individuals with type 2 diabetes (T2D), who are at an increased risk. However, this inflammation has been difficult to detect because the currently used biomarkers have limited accuracy in identifying inflammation in the coronary arteries.
Exiting advancements have been made in the field of coronary CT angiography (CCTA). CCTA enables the measurement of the pericoronary adipose tissue (PCAT) attenuation, which refers to the fat tissue surrounding the coronary arteries. PCAT and the coronary arteries have a bidirectional communication, and when PCAT is exposed to high inflammation it causes the fat-structure to change. These structural changes in PCAT can be detected with a CCTA scan. Additionally, a CCTA scan can assess plaque characteristics, such as the amount of plaque (burden), the type of plaque (composition), and the presence of high-risk plaque features, all of which, are linked to major adverse cardiovascular events (MACE). Furthermore, recent studies have shown that PCAT attenuation can predict cardiac events and mortality.
The PCAT-DM study is a post-hoc analysis from the CARPE-DM study (NCT03016910). The goal of this prospective study is to investigate whether PCAT attenuation and/or PCAT changes are associated with high-risk plaque features, plaque composition and burden. Additionally, the study aims to investigate whether PCAT attenuation and/or PCAT changes can predict development of MACE over a follow-up period of 7 years.
Setting and study population:
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
- 否
入选标准
- •Above 18 years
- •Capable of giving written informed consent
- •Type 2 diabetes mellitus
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
Baseline PCAT attenuation and plaque features at the 12-month CCTA
时间窗: 12 months
Cardiac assessments at the 12-month CCTA scan include: Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume). High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC).
Changes in PCAT attenuation and plaque features at the 12-month CCTA
时间窗: 12 months
Changes in PCAT attenuation from baseline to the 12-month CCTA will be measured. Cardiac assessments at the 12-month CCTA scan include: Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume). High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC).
Baseline PCAT attenuation and MACE
时间窗: 7 years
Baseline PCAT attenuation will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan.
Changes in PCAT attenuation after 12-month and MACE
时间窗: 7 years
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan.
次要结局
- PCAT attenuation and de novo heart failure(7 years)
- PCAT attenuation and non-fatal acute myocardial infarction(7 years)
- PCAT attenuation and non-fatal stroke(7 years)
- PCAT attenuation and hospitalization for HF(7 years)
- PCAT attenuation and CV death(7 years)
- PCAT attenuation and PAD(7 years)
- PCAT attenuation and CV revascularization(7 years)
- PCAT attenuation and all-cause mortality(7 years)
- Changes in PCAT attenuation and non-fatal acute myocardial infarction(7 years)
- Changes in PCAT attenuation and hospitalization for HF(7 years)
- Changes in PCAT attenuation and non-fatal stroke(7 years)
- Changes in PCAT attenuation and PAD(7 years)
- Changes in PCAT attenuation and CV death(7 years)
- Changes in PCAT attenuation and CV revascularization(7 years)
- Changes in PCAT attenuation and all-cause mortality(7 years)
- Changes in PCAT attenuation and de novo heart failure(7 years)