The Atlantic CPORT Primary PCI Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,726
- 试验地点
- 14
- 主要终点
- Composite incidence of death, non-fatal reinfarction and stroke.
研究概览
简要总结
The proposed study is a registry of patients treated with primary angioplasty for acute myocardial infarction.
The aim of this registry is to define the outcomes of patients treated for acute, ST-segment myocardial infarction (STEMI) at community hospitals without on-site cardiac surgery programs that have completed the Cardiovascular Patient Outcomes and Research Team (C-PORT) Primary Angioplasty Development program. The primary medical outcome for the registry is the combined incidence of death, recurrent non-fatal myocardial infarction and stroke.
详细描述
The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction.
Secondary endpoints include:
- composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months
- specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender
- incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •age > 18 years
- •ability to give informed consent
- •acute myocardial infarction with
- •> 30 mins ongoing ischemic cardiac pain at presentation and > 0.1 mv ST-segment elevation in 2 or more contiguous ECG leads or
- •new or suspected new Left Bundle Branch Block (LBBB) or
- •> 0.1 mv ST-segment depression in V1 and V2 consistent with true posterior infarction
- •rescue PCI for failed thrombolytics
- •cardiogenic shock - (defined as systolic blood pressure <80 mmHg sustained for more than 30 minutes despite correction of non-myocardial factors (hypovolemia, acidosis, arrhythmia, etc) or requirement for pressors and/or intra-aortic balloon pump (IABP) to sustain systolic blood pressure > 80 mmHg)
- •Exclusion Criteria
- •inability to obtain informed consent (surrogate consent may be obtained if approved by your IRB)
排除标准
- 未提供
结局指标
主要结局
Composite incidence of death, non-fatal reinfarction and stroke.
时间窗: 6 weeks after myocardial infarction
The primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction. Secondary endpoints include: 1. composite of death, recurrent non-fatal MI and stroke at hospital discharge and at 6 months 2. specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender 3. incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest
次要结局
未报告次要终点
