French Cohort of Myocardial Infarction Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- In-hospital outcomes
研究概览
简要总结
Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively.
The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.
详细描述
The FRENCHIE registry is a French multicenter prospective observational study. All the eligible consecutive patients admitted within 48 hours after symptom onset in a cardiac ICU for an acute myocardial infarction.
This hospital registry will be linked to the national databases, in order to collect follow-up clinical outcomes and health care consumption.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Myocardial infarction (MI) within 48h of symptom onset, characterized by the typical increased or fall of troponin (or CPKMB) associated with at least one of the following elements :
- •Symptoms compatible with myocardial ischemia
- •Appearance of pathological Q waves
- •ST- T changes compatible with myocardial ischemia (ST segment elevation or depression, T-wave inversion)
- •Written consent.
- •Covered by French medical insurance ("Sécurité Sociale")
排除标准
- •Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure
- •AMI diagnosis invalidated in favor of another diagnosis
结局指标
主要结局
In-hospital outcomes
时间窗: Through the end of initial hospitalization, an average of 5 days
To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke
Lipopretein 1 evolution
时间窗: 9 months after the end of initial hospitalization
To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.
In-hospital mortality
时间窗: Through the end of initial hospitalization, an average of 5 days
In-hospital mortality
次要结局
- Non cardiovascular outcomes during follow-up(Up to 20 years)
- Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management(Up to 20 years)
- Oral comorbidities(Up to 20 years)
- Evaluate the path of care combined with patient care practices following an acute myocardial infarction(Up to 20 years)
- Cardiovascular outcomes during follow-up(Up to 20 years)
- Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management(Up to 20 years)
- Sleep disordered breathing comorbidities(Up to 20 years)
- Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients(Up to 20 years)
- Cost-utility: incremental (or decremental) cost-utility ratio during follow-up(Up to 20 years)