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临床试验/NCT02201264
NCT02201264已完成不适用

The Atlantic CPORT Primary PCI Registry

Johns Hopkins University14 个研究点 分布在 1 个国家目标入组 6,726 人开始时间: 2006年4月最近更新:
适应症

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:

  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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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