CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Research of potential new markers
研究概览
简要总结
ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort).
The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
- •Management in primary ACT
- •Prior oral informed consent followed by signed informed consent as soon as possible.
排除标准
- •Diagnosis of STEMI not confirmed on angiography
- •Inability to give the subject informed information
- •Lack of coverage by a social security scheme
- •Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....)
- •Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman.
- •Deprivation of civil rights (curators, guardianship, safeguard of justice)
研究组 & 干预措施
Cohort group
patient with ST-segment elevation myocardial infarction.
干预措施: Quality of life questionaries (Behavioral)
Cohort group
patient with ST-segment elevation myocardial infarction.
干预措施: Biocollection (Biological)
Cohort group
patient with ST-segment elevation myocardial infarction.
干预措施: MRI (Other)
结局指标
主要结局
Research of potential new markers
时间窗: 1 year
Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)
次要结局
- Pharmacoepidemiology of myocardial infarction.(5 years)
- Calculation of infarct size on MRI(1 month)
- Events between inclusion and 5 years follow-up(5 years)