Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 10
- 主要终点
- Definite stent thrombosis
研究概览
简要总结
This registry will provide information about the efficacy and safety of cangrelor in a very high-risk group of patients with acute myocardial infarction undergoing PCI. It will not only include patients with cardiogenic shock, but a variety of patients not able to swallow tablets, such as those after CPR and/or with invasive or non-invasive ventilation. Therefore it will provide information about the use of cangrelor beyond the current knowledge.
详细描述
This registry is a non-interventional, multicentre, retrospective cohort study in patients with acute myocardial infarction undergoing PCI after CRP, ventilated and/or with cardiogenic shock.
The study is purely observational; data will be documented retrospectively based on available medical records. No additional data will be collected, no study-related treatment will be initiated.
About 10 - 20 high-volume PCI clinics in Germany treating patients with myocardial infarction are eligible for participation. Participating sites will be given a maximum of 6 months for retrospectively documenting eligible patients.
Eligible are all patients with acute myocardial infarction (STEMI, NSTEMI) who underwent PCI after CRP, ventilated and/or with cardiogenic shock and were treated with cangrelor during index procedure. It is planned to enrol about 400 patients in total. Patient characteristics, procedural details and clinical events occurring during the period between index MI and discharge or death (whichever came first) will be documented based on the relevant existing medical charts of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Acute Myocardial infarction (NSTEMI or STEMI)
- •PCI with stent implantation
- •Treatment with cangrelor during index procedure
- •At least one of the following criteria:
- •CPR prior to PCI
- •Cardiogenic shock
- •Heart failure with the need for mechanical or non-invasive ventila-tion
排除标准
- •No explicit medical exclusion criteria are stated to avoid selection bias.
结局指标
主要结局
Definite stent thrombosis
时间窗: from procedure for index MI up to 48 hours
Rate of stent thromboses
Recurrent myocardial infarction
时间窗: from procedure for index MI up to 48 hours
Rate of recurrent myocardial infarction according to the universal definition of MI
次要结局
- Recurrent myocardial infarction(from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days)
- Mortality(from procedure for index MI until discharge from hospital; up to 30 days)
- Definite stent thrombosis(from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days)
- Bleeding complications(from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days)