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
- 已完成
- 入组人数
- 281
- 试验地点
- 3
- 主要终点
- Heart failure stage
研究概览
简要总结
Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.
The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction.
Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:
- Descriptive epidemiology of myocardial infarction and myocardial reperfusion
- Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
- Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death
- Quality of life and personal consequences, family, professional and social myocardial infarction
- Research of new diagnostic and prognostic biomarkers
- Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 old
- •Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
- •Primary Percutaneous coronary intervention (PCI)
排除标准
- •Diagnosis of STEMI not confirmed by angiography
- •Refusal to participate in the study or to sign the consent
- •Impossibility to give information to the subject about the study
- •Lack of medical social coverage
- •Obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent)
- •Deprivation of civil rights
- •participating to another interventional study
研究组 & 干预措施
STEMI cohort
Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :
- an additional blood sampling at 6 months
- an additional electrocardiogram (ECG) at 6 months
- Magnetic Resonance Imaging (MRI)
- Quality of life questionnaire
干预措施: Blood sampling (Biological)
STEMI cohort
Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :
- an additional blood sampling at 6 months
- an additional electrocardiogram (ECG) at 6 months
- Magnetic Resonance Imaging (MRI)
- Quality of life questionnaire
干预措施: ECG (Procedure)
STEMI cohort
Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :
- an additional blood sampling at 6 months
- an additional electrocardiogram (ECG) at 6 months
- Magnetic Resonance Imaging (MRI)
- Quality of life questionnaire
干预措施: MRI (Device)
STEMI cohort
Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :
- an additional blood sampling at 6 months
- an additional electrocardiogram (ECG) at 6 months
- Magnetic Resonance Imaging (MRI)
- Quality of life questionnaire
干预措施: Quality of life questionnaire (Other)
结局指标
主要结局
Heart failure stage
时间窗: Up to 3 years after myocardial infarction
Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification
次要结局
- Infarct size(1 month after myocardial infarction)
- Cardiac enzymes rate(12 month after myocardial infarction)
- EQ-5D score(12 month after myocardial infarction)