NCT02335086已完成不适用
DNA Damage and Repair Proteins In Patients With Atherosclerotic Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Difference in DNA ligase activity in peripheral blood mononuclear cells of patients with stable angina and non-ST-elevation myocardial infarction
研究概览
简要总结
The purpose of this study is:
- To examine the association between stable and unstable coronary artery disease (CAD) with markers of DNA damage and repair,
- To examine the association between plaque morphology as assessed by frequency-domain optical coherence tomography (FD-OCT) and markers of DNA damage and repair in order to identify potential markers of plaque instability,
- To examine the association between markers of DNA damage and repair and major adverse cardiovascular events defined as death, MI and unplanned percutaneous or surgical revascularization,
详细描述
Hypotheses ----------------
We hypothesise that defective DNA damage response is an important aetiological factor in the development of CAD, underlying CAD severity and development. If this hypothesis is true, then we predict that:
- There is differential expression of markers of DNA damage and repair in patients with stable angina, a model of stable CAD, and patients with non ST-elevation myocardial infarction (NSTEMI), a model of unstable CAD.
- Differential expression of markers of DNA damage and repair correlate with plaque morphology and stability as defined by FD-OCT,
- Markers of DNA damage and repair can serve as distinguishing markers of stable and unstable CAD,
Methodology
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
- 未提供
排除标准
- •-----------------------
- •Presentation with ST-elevation MI (STEMI),
- •Decompensated heart failure, hypotension, shock, refractory ventricular tachycardia, acute conduction disorders, left ventricular ejection fraction ≤ 30%,
- •Prior coronary revascularization,
- •Any form of surgery up to three months prior to enrolment,
- •Active inflammatory disorders,
- •Bleeding diathesis,
- •Known allergy, hypersensitivity, or contraindication to aspirin, heparin, or thienopyridines,
- •Life expectancy less than 1 year,
- •Diabetes mellitus.
- •Angiographic:
- •Left main coronary artery stenosis ≥ 50%,
- •Coronary artery bypass surgery planned within one year of the PCI,
- •Anatomical conditions precluding three-vessel FD-OCT (significant tortuosity, severe calcification, chronic total occlusion).
结局指标
主要结局
Difference in DNA ligase activity in peripheral blood mononuclear cells of patients with stable angina and non-ST-elevation myocardial infarction
时间窗: 18 months
DNA ligase (DNA repair enzyme) activity measured using units per well, in peripheral mononuclear cells between stable and NSTEMI patients undergoing percutaneous coronary intervention.
次要结局
- Plaque fibrous cap thickness and its association with major adverse cardiovascular events (MACE)(18 months)
研究者
研究点 (2)
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