A Prospective Registry to Assess Atherosclerosis Risk Factors and Their Relationship With Coronary Plaque Properties and Genetic Variations in Patients With Early Atherosclerosis of Unclear Origin.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Genetics
研究概览
简要总结
Atherosclerosis and its complications are a global problem. There are several widely known and proven risk factors that promotes atherogenesis in the majority of patients. However, significant proportion of apparently healthy and young patients with cardiovascular disease but yet without recognized atherogenesis promoting risk factors can be observed in clinical practice. It highlights the need of new risk markers for early atherosclerosis diagnostics to prevent serious cardiovascular complications in these patients and in population in general. The interest in the negative impact of genetic variance, gene regulation on atherogenesis is growing. Therefore the purpose of this study is to analyze the impact of genetic variance and microRNA expression on early atherosclerosis development in the population of young, apparently healthy patients with coronary atherosclerosis. The primary hypothesis is that the group of patients with premature atherosclerosis have common genetic variations promoting early atherosclerosis development. The secondary hypothesis is that specific circulating microRNA expression (miR-126, miR-145 and miR-155) correlate with plaque lipid core by near infrared spectroscopy (NIRS) analysis.
详细描述
Patients with early atherosclerosis undergoing coronary angiography or percutaneous transluminal coronary angioplasty (PTCA) at Pauls Stradins Clinical University Hospital, Latvia will be included in the early atherosclerosis registry. Patients without explicit atherosclerosis risk factors undergoing coronary angiography or PTCA will undergo near-infrared spectroscopy imaging and blood samples for microRNA expression evaluation and genetic analysis will be obtained.
Exclusion criteria:
- Refusion to participate in the registry
- Men ≥55 years and women ≥65 years
- Coronary artery atherosclerosis < 50% or ≥50% without proven ischaemia and planned revascularization or no history of coronary artery revascularization
Exclusion criteria for additional genetic analysis and intravascular coronary imaging:
- Diabetes mellitus
- Serum total cholesterol ≥ 7 mmol/l and/or LDL ≥ 5 mmol/l
- Family hypercholesterolemia
- Positive family history of cardiovascular disease (myocardial infarction, sudden cardiac death or cardiovascular disease of first-degree relatives at a young age - men <55 years, women <65 years)
- ≥20 pack years of smoking
- Malignant or resistant hypertension ≥ 10 years
- Body mass index ≥40 kg/m2
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Genetics
时间窗: 12 months
Correlation between intravascular plaque characteristic data and gene variations in LDLR (low density lipoprotein receptor), APOB (Apolipoprotein B), PCSK9 (proprotein convertase subtilisin/kexin type 9) and LDLRAP1 (Low Density Lipoprotein Receptor Adaptor Protein 1).
次要结局
- Major adverse cardiovascular events (MACE)(12 months)
- Target lesion revascularization(12 months)
- Intravascular coronary imaging(12 months)
研究者
Karlis Trusinskis
Professor
Pauls Stradins Clinical University Hospital