EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.
详细描述
This is a prospective, multi-center, non-randomized, observational registry study of STEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial tissue features and functional changes in STEMI patients.
- To identify CMR-derived indices that are associated with adverse clinical outcomes.
- To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •STEMI patients who have had CMR imaging performed and have provided written consent.
- •Patents older than 18 years old with myocardial infarction diagnosed by:
- •typical ischemic symptom,
- •New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
- •elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL);
- •confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
- •Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.
排除标准
- •Patient who is unable to comply with the follow-up schedule.
- •Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
- •Patient has a life expectancy of less than 6 months due to any condition.
结局指标
主要结局
Major adverse cardiac events
时间窗: 1 year
MACE
次要结局
未报告次要终点