Systemic, Pancoronary and Local Plaque Vulnerability for Image-based Prediction of Acute Coronary Syndromes - the VIP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MACE rate - Major adverse cardiovascular events
研究概览
简要总结
• The aim of the VIP study is to investigate the impact of vulnerability markers (inflammatory serum biomarkers for systemic vulnerability, coronary shear stress and vulnerability mapping for pancoronary vulnerability, and imaging-based plaque features for systemic vulnerability) on the rate of major adverse cardiovascular events caused by progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation myocardial infarction who undergo revascularization of the culprit lesion during the acute event. Furthermore, the study will evaluate the rate of progression of non-culprit lesions towards a higher degree of vulnerability, based on coronary computed tomography angiographic assessment at 1 year after enrollment.
详细描述
The project is a prospective, cohort, mono-centric study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed.
The project will include 100 subjects who present ST and non-ST segment elevation myocardial infarction at 30 days prior to study enrollment, who underwent emergency revascularization of the culprit lesion. Samples for systemic serum biomarkers for myocardial injury, myocardial strain and enhanced systemic inflammation will be collected at the moment of the acute event. All patients will undergo coronary CT angiography, cardiac perfusion CT and intracoronary imaging procedures (Intravascular ultrasound - IVUS; Optical Coherence Tomography - OCT) at the moment of enrollment in the study, for complex assessment of non-culprit coronary lesions. The endothelial coronary shear stress will be calculated with imaging post-processing techniques on the CT data acquired at baseline, by using computational fluid dynamics.
The study will be conducted over a period of 3 years, in which patients will be examined at baseline, and during several follow-up visits. At the one-year follow-up, the study subjects will undergo CT coronary angiography for re-evaluation of the non-culprit lesions, in the prospects of analyzing the rate of plaque progression towards a higher degree of vulnerability. At the end of the 3-year period, patients will be assessed about the occurrence of major adverse cardiovascular events and the rate or revascularization for non-culprit lesions.
Study objectives:
Primary: to investigate the association between systemic, pancoronary and local vulnerability features of coronary plaques and the risk for major adverse cardiac events - MACE (all-cause mortality, cardiovascular death, myocardial infarction, repeated revascularization, repeated hospitalizations for cardiovascular related incidents, cerebrovascular events) during a 3-year follow-up.
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 aged over 18 years old that have signed the written informed consent;
- •Patients with ST and non-ST segment elevation myocardial infarction (as stated in the Third Universal Definition of Myocardial Infarction) at 30 days prior to randomization;
排除标准
- •unwillingness or incapacity to provide informed consent (and if consent of legal guardian or family is not available);
- •acute myocardial infarction at the moment of randomization (as these patients are referred to the hospital for emergency invasive coronary angiography and revascularization)
- •conditions that present an estimated life expectancy of under 5 years;
- •acute renal failure or terminal stage chronic kidney disease;
- •pregnancy or lactation and women of reproductive age who are not using any contraceptive method;
- •allergy and history of allergic reactions to iodine contrast media;
- •active malignancy or malignancy within the last 1 year prior to enrollment;
- •patients who, in the opinion of the investigators are not compliant and will not present for study visits.
结局指标
主要结局
MACE rate - Major adverse cardiovascular events
时间窗: 36 months
Acute coronary syndromes (unstable angina, ST and non-ST elevation myocardial infarction), emergency revascularization of non-culprit lesions, repeated hospitalizations for cardiovascular reasons, acute cerebrovascular event.
次要结局
- Progression rate of CT markers for coronary plaque vulnerability(12 months)
- Severity progression of non-culprit coronary lesions(12 months)