Evaluation of Tryptase as a Biomarker of Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- serum level of tryptase as a biomarker in coronary
研究概览
简要总结
The main aim of this study will evaluate differences in serum levels of tryptase in study population. Will be selected a number of 350 patients hospitalized for coronary heart disease.
详细描述
A series of scientific studies have evaluated the tryptase as a biomarker of coronary plaque instability, in the course of ischemic heart disease. Among these, the most recent and 'outcome' is better defined by Meixiang Xiang study, which has been conducted in 2011 on 270 patients. This study evaluated and compared the levels of tryptase in four populations:
- acute myocardial infarction (31 subjects)
- unstable angina (108 subjects)
- stable angina (36 subjects)
- coronary artery disease with coronary stenosis <50% (95 subjects). In this Chinese population the final evaluations have led to define the tryptase as a marker independent of instability of the atheromatous plaque.
In reference to the fact that there is still some correlation between tryptase and coronary plaque instability and clinical symptoms, we propose a verification study of the role of tryptase as a biomarker in acute coronary conditions by studying a large population of Italian subjects in the acute phase of pathology and follow up.
The work will be conducted on 4 patient population:
- acute coronary syndrome with ST elevation on electrocardiogram;
- acute coronary syndrome without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)
- noncritical coronary artery disease with coronary stenosis <50%;
- aortic aneurysms. Secondary endpoints will evaluate the role of tryptase in the event of major cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects aged 18 to 80 years
- •patients with clinical manifestations have been discovered and documented symptoms of coronary heart disease
- •all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study
排除标准
- •patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
- •those who deny consent to participate
结局指标
主要结局
serum level of tryptase as a biomarker in coronary
时间窗: 6 months
dose level of serum tryptase already performed by venipuncture from diagnostic practices
次要结局
- Tryptase and major cardiovascular events(6 months)