Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 2
- 主要终点
- Changes in total atheroma volume (TAV)
研究概览
简要总结
This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.
详细描述
This is a combined cohort study with retrospectively and prospectively enrolled patients. Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. For patients referred to invasive coronary angiography, intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) will be performed. For all the prospectively enrolled patients, plasma and serum blood samples will be collected.
The purpose of this study is to investigate the natural history of coronary atherosclerotic plaques in this population. Comprehensive morphological plaque analysis will be performed to evaluate total atheroma volume (TAV), percent atheroma volume (PAV), plaque composition, high risk plaque features, and characteristics of perivascular adipose tissue (PVAT). Functional analysis will also be conducted to calculate hemodynamic parameters such as wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RTT), transverse WSS (transWSS), axis plaque stress (APS), fractional flow reserve (FFR), and δFFR across lesions. The associations of these morphological and functional parameters with plaque progression and the onset of major adverse cardiovascular events (MACEs) will be analyzed. In addition, the impact of pharmacological treatments and the levels of cardiometabolic factors on coronary plaque progression will also be investigated.
In the subpopulation who also receive intracoronary imaging examinations, intracoronary imaging modalities will be used to refine the inner and outer vessel contours, improve the accuracy of plaque composition characterization, and aid in the discovery of novel high-risk plaque features by coronary CTA.
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
- •Age ≥ 18 years
- •Clinically significant angina pectoris, or suspected CAD
- •Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.
排除标准
- •Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- •Receive percutaneous coronary intervention (PCI) within 6 months
- •Prior history of myocardial infarction or heart failure
- •Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- •Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30 ml/min)
- •Familial hypercholesterolemia
- •Estimated survival ≤ 1 year
- •Malignant tumor
- •Pregnant or lactation, or have the intention to give birth within one year
- •Poor coordinance, unable to follow-up
结局指标
主要结局
Changes in total atheroma volume (TAV)
时间窗: 24 months
changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
次要结局
- Major cardiovascular events (MACEs)(5 years)
- Cardiovascular death(5 years)
- Changes in calcified plaque volume(24 months)
- Changes in perivascular adipose tissue (PVAT) volume(24 months)
- Myocardial infarction(5 years)
- Unplanned revascularization(5 years)
- Changes in non-calcified plaque volume(24 months)
- Changes in necrotic core volume(24 months)
- Changes in fibrous plaque volume(24 months)
- Changes in fibrousfatty plaque volume(24 months)
- Changes in high-risk plaque (HRP) features(24 months)
- Changes in perivascular adipose tissue (PVAT) density(24 months)
- Changes in perivascular adipose tissue (PVAT) distribution(24 months)