NCT03551756Unknown不适用
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Biomarker assessment
研究概览
简要总结
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
详细描述
This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Group 1: Heart Failure with Coronary Artery Disease Subjects
- •Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
- •Significant underlying coronary artery disease as evidenced by:
- •previous myocardial infarction
- •prior coronary artery bypass graft
- •50% coronary stenosis of one or more arteries and/or
- •history of percutaneous coronary intervention with or without stenting
- •Age 18 years or older at the first screening visit
- •Group 2: Healthy Subjects
- •Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects
排除标准
- •Documented history of "severe" valvular disease
- •Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
- •Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
- •Known significant cardiovascular or hematological condition
- •Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
- •Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
- •History of Asthma
- •History of peptic ulcers
结局指标
主要结局
Biomarker assessment
时间窗: 1 day
Exploratory biomarker analysis
次要结局
未报告次要终点
研究者
研究点 (3)
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