Definition: Impact of Coronary Plaque Geometry on Plaque Vulnerability and Their Association With the Risk of Future Cardiovascular Events in Patients With Chest Pain Undergoing Coronary Computed Tomographic Angiography - the GEOMETRY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
The aim of GEOMETRY study is to investigate the correlation between coronary plaque geometric modifications and lesion vulnerability in patients with suspected coronary artery disease referred for cardiac computed tomography angiography (CCTA). Furthermore the study will evaluate the impact of plaque eccentricity and morphology on the rate of major adverse cardiovascular events (MACE) for a 2 years follow-up period.
详细描述
Coronary artery disease (CAD) remains the leading cause of mortality and morbidity worldwide. Early detection of CAD may reduce the incidence of myocardial infarction by improving primary prevention and providing more effective treatment methods. A step in this direction is identifying the pattern of coronary plaques which are prone to rupture. Coronary computed tomography angiography (CCTA) has emerged recently as a reliable noninvasive tool used in the evaluation of coronary arteries. Some features related to plaque composition and morphology such as low attenuation plaques, spotty calcification, positive remodeling or napkin ring sign, were already identified as vulnerability markers. However the role of lesion geometry on plaque vulnerability was not investigated yet.
This is a prospective, cohort, single-center study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed.
The study will include 1.000 subjects with suspected CAD who are referred to CCTA by the attending physician and in which presence of at least one coronary plaque is confirmed by CCTA.
Plaque burden, composition, and morphology will be assessed for each plaque. Longitudinal and transversal eccentricity will be also assessed in each plaque and in all cases, eccentricity index will be calculated in cross-section plane at the degree of maximum stenosis in order to determine the position of the remaining circulant lumen and to classify the plaque into concentric and eccentric lesion.
The study will be conducted over a period of 3 years, in which patients will be examined at baseline, and will be followed-up for 2 years for occurrence of MACE.
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
- •Patients with suspected coronary artery disease (CAD) and pre-test probability of CAD between 15% and 85%, who undergo CCTA, and in whom CCTA has identified presence of at least one coronary plaque
- •Ability to provide informed consent
- •Age grater then 18 years
排除标准
- •Patients with pre-test probability of CAD >85% or <15%
- •Electrocardiographic evidence of STEMI
- •Presence of pre-existing CAD including prior myocardial infarction
- •History of coronary artery revascularization (by percutaneous coronary intervention, stent or bypass graft surgery)
- •Atrial fibrillation or other irregular rhythm
- •Unwillingness or incapacity to provide informed consent
- •Allergy to iodine contrast media
- •Inability to tolerate beta-blocker medication
- •Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis
- •Pregnant women or lactation
- •Active malignancy or malignancy within the last 5 year prior to enrolment
- •Conditions associated with an estimated life expectancy of under 2 years
- •Coronary calcium score >1000
结局指标
主要结局
Major adverse cardiovascular events
时间窗: Month 24
Incidence of MACE during follow-up
次要结局
- Coronary plaque vulnerability associated to plaque eccentricity(Month 24)