Prediction of Primary Cardiovascular Events Using a Multimarker Approach (Prospective Clinical Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 主要终点
- Number Of respondents wirh cardiovascular death
研究概览
简要总结
The study of biochemical risk factors for cardiovascular diseases is important not only for analysis, but also for preventive measures, given that changes in the level of biomarkers can be detected before the first clinical manifestations of CVD. Accordingly, patients at high CV risk may have additional motivation to lead a healthy lifestyle. In addition, information on biochemical risk markers can be used to optimize the clinical management of patients.
详细描述
Recruitment of 1500 people randomly without previous cardiovascular events. Examination, questioning of patients, laboratory tests. Patient follow-up for 6 years. Registration of the facts of the occurrence of cardiovascular events.
Cohort study with a retrospective and prospective component
Stage I (Conducted in 2014 as part of the scientific and technical project "Environmental risks and public health")
- Questionnaire and general clinical examination (anthropometry, measurement of blood pressure, BMI, WC)
- determination of cholesterol, glucose and total cardiovascular risk according to the SCORE scale
- Determination of the quality of life, the level of depression and anxiety, the level of physical activity.
For an in-depth biochemical blood test for onco- and cardiomarkers, the MILLIPLEX MAP Human panel was used. This panel allows you to simultaneously study 23 onco- and 11 cardiac markers, which are the most common among oncological and cardiac diseases. Tumor markers included: alpha-fetoprotein (Afp), carbohydrate antigen 125 (CA125), carbohydrate antigen 15-3 (CA15-3), cancer embryonic antigen (CEA), cytokeratin fragment 19 (CYFRA21-1), fibroblast growth factor 2 (FGF2), human epididymis protein 4 (HE4), hepatocyte growth factor (HGF-α), interleukin 6 (IL6), interleukin 8 (IL8), leptin (LEPTIN), anti-Mullerian hormone (MIF), osteopontin (OPN ), prolactin (PROLACTIN), common prostate specific antigen (PSAtotal), cystatin C (SCF), apoptosis inducer (SFAS), transforming growth factor (TGF-α), tumor necrosis factor (TNF), TRAIL, vascular endothelial growth factor ( VEGF), Beta chorionic gonadotropin (bHCG), apoptosis inducer L (SFAS) L.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •respondents living in the territory of the Republic of Kazakhstan from 25 to 65 years without previous cardiovascular events.
- •Exclusion criteria:
- •pregnant women;
- •persons with mental and severe neurological diseases;
- •survivors of an acute event associated with atherosclerosis;
- •persons with diagnosed chronic forms of coronary artery disease;
- •persons with verified CHF;
- •persons with myocarditis and cardiomyopathies of various origins,
- •congenital and acquired heart defects,
- •atherosclerosis of peripheral arteries.
排除标准
- 未提供
结局指标
主要结局
Number Of respondents wirh cardiovascular death
时间窗: 66 months
death reported as a complication of cardiovascular disease
number of respondents with stroke or transient ischemic attack
时间窗: 66 months
stroke was defined as a sudden onset of nonconvulsive and focal neurological deficit due to ischemia or hemorrhage that lasts \>24 hours, and it is transient ischemic attack if neurological recovery occurred within 24 hours. \&e diagnosis of stroke and the transient ischemic attack was based on the disease history, neurological examination, and all available clinical data, including computed tomography (CT)/magnetic resonance imaging (MRI) results.
Number of respondents with Coronary heart disease
时间窗: 66 months
Coronary heart disease included myocardial infarction, sudden cardiac death, and newly diagnosed angina. The criteria for MI were at least two of the following: (1) typical symptoms, including prolonged severe anterior chest pain; (2) elevated cardiac enzymes-higher than twice the upper limit of the standard values; sudden cardiac death within 1 hour of the acute condition onset; (3) progressive diagnostic electrocardiographic changes. The cases of newly diagnosed angina were determined based on typical angina-type pain, reversed by the use of nitrates, confirmed by a doctor's examination, and via the electrocardiography (ECG) exercise test.
次要结局
未报告次要终点