Coronary Atherosclerosis in Outlier Subjects: Protective and Individual Risk Factor Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 544
- 试验地点
- 10
- 主要终点
- Number of patients in each Group with a cardiovascular Event
研究概览
简要总结
The risk of developing clinical manifestations of ischemic heart disease is currently assessed by using integrated multifactorial prediction models based on the presence of non-modifiable risk factors, such as age, gender and a family history of early ischemic heart disease along with risk factors which are defined as conventional, such as arterial hypertension, hypercholesterolemia, cigarette smoking and diabetes mellitus.
However, if the relationship between risk factors and ischemic heart disease clinical manifestations shows some limitations, the relation between risk factors and the coronary atherosclerosis process underlying most ischemic syndromes seems to be even weaker.
In fact there is significant individual variability and the limits of such relationship are demonstrated by a non negligible number of subjects at the outliers of mean behaviour of the prediction model. At one outlier, in the presence of multiple risk factors, these subjects do not develop neither coronary events nor coronary atherosclerosis whereas, at the other, coronary events and disease occur in the absence of risk factors.This study aims at detecting new protection and susceptibility factors, thus enabling to formulate new etiopathogenetic hypotheses concerning coronary atherosclerosis and to identify new therapeutic targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group A: subjects with total absence of coronary atherosclerosis and 3 or more risk factors (reported by the subject or documented at the MDCT)
- •Group B: subjects with diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification and 0-1 risk factor (reported by the subject or documented at the MDCT) with the exclusion of patients with type 1 or type 2 diabetes mellitus as single risk factor.
- •Using the same criteria, two control populations will be selected, with a case:control 1:1 ratio, consisting in:
- •Group C: subjects with total absence of coronary atherosclerosis and 0-1 risk factor (reported by the subject or documented at the MDCT)
- •Group D: subjects with diffuse coronary atherosclerosis extended to more than 5 of the 16 segments according to the American Heart Association classification and 3 or more risk factors (reported by the subject or documented at the MDCT) with the exclusion of patients with type 1 or type 2 diabetes mellitus as single risk factor.
排除标准
- •common contraindications to MDCT (chronic renal failure with serum creatinine > 2.0 mg/dl, suspected pregnancy, arrhythmias, body mass index > 40, allergy to iodized contrast agent).
- •previous cardiovascular events (heart failure, acute myocardial infarction, unstable angina, chronic stable angina, previous percutaneous or surgery coronary revascularization) both clinically evident and found by conventional diagnostic methods previous performed.
- •subjects which MDCT does not meet the quality control criteria defined below in the protocol.
- •patients with previous documented or identified at the moment of MDCT such as dilated cardiomyopathy regardless of etiology, obstructive hypertrophic cardiomyopathy, atrial fibrillation, myocarditis and inflammatory vascular disease.
结局指标
主要结局
Number of patients in each Group with a cardiovascular Event
时间窗: 5 years
次要结局
- Polymorphisms associated with chromosome 9 in each patient(At enrollment visit)