Inflammation and Acute Coronary Syndromes (ACS) - Novel Strategies for Prevention and Clinical Management
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 4
- 主要终点
- Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization
研究概览
简要总结
Subproject 1: Optimize prevention after acute coronary syndromes (ACS) by improving caregiver and patient education (http://elips.hug-ge.ch/eng/index_eng2.htm)
Subproject 2: Discover novel genomic biomarkers of ACS in leukocyte subsets by means of analyzing gene expression profiles and function
Subproject 3: Evaluate novel diagnostic and prognostic biomarkers in soluble form in blood/plasma and urine
Subproject 5: Visualize the vulnerable plaque using intravascular ultrasound/optical coherence tomography (IVUS/OCT) and correlate with outcome and biomarkers
Subproject 7: Characterize the effects of inflammation on progenitor/stem cell-mediated repair after ACS by means of analyzing gene expression profiles and function
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
- 是
入选标准
- •All patients with age ≥ 18 years presenting within 5 days (preferably within 72 hours) after pain onset with the main diagnosis of ACS (acute myocardial infarction: STEMI /NSTEMI and threatened infarction: unstable angina pectoris), who enter the hospital: The patients show symptoms, which are compatible with angina pectoris (chest pain, dyspnoea) and at least one of the following characteristics:
- •persistent ST-segment elevation or depression, T inversion or dynamic ECG changes, new left bundle branch block (LBBB)
- •Evidence of positive troponin by local laboratory reference values with a rise and/or fall in serial troponin levels
- •known coronary artery disease, specified as status after myocardial infarction, CABG, or PCI or newly documented ≥50% stenosis of an epicardial coronary artery during the initial catheterization
排除标准
- •Severe physical disability,
- •Dementia (inability to comprehend study), OR
- •Less than 1 year of life expectancy (for non-cardiac reasons).
结局指标
主要结局
Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization
时间窗: 30 days and 12 months follow-up
次要结局
- SP2/SP3/SP5: temporal change in biomarkers (12 months).(SP2/SP3/SP5: 13 months)
- Correlation with plaque burden and neointimal thickness assessed by IVUS/OCT imaging in ST segment elevation myocardial infarction (STEMI) subgroup (13 months)(13 months)