Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- C Reactive Protein (Area Under the Curve)
研究概览
简要总结
Acute myocardial infarction is characterized by an intense inflammatory response.
The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
- •Planned or completed coronary angiogram for potential intervention
排除标准
- •Inability to give informed consent
- •Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
- •Pregnancy
- •Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
- •Preexisting severe left ventricular dysfunction (EF<20%)
- •Preexisting severe valvular heart disease
- •Known active infections (acute or chronic)
- •Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
- •Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
- •Known active malignancy of any type, or prior diagnosis in the past 10 years
- •Anticipated need for cardiac or major surgery
- •Known active cancer (or prior diagnosis of cancer within the past 10 years)
- •Known Immunoglobulin A (IgA) deficiency
研究组 & 干预措施
Alpha-1 anti-trypsin (AAT)
We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
干预措施: Alpha 1-Antitrypsin (Drug)
结局指标
主要结局
C Reactive Protein (Area Under the Curve)
时间窗: 14 days
A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.
次要结局
- Left Ventricular End-systolic Volume Change(3 months)