EARLY-MYO-CMR-II (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in NSTEMI) Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events(MACE)
研究概览
简要总结
The purpose of this registry is to depict the myocardial tissue characteristics in NSTEMI 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 2000 NSTEMI 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 NSTEMI 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 2000 NSTEMI patients in 10 sites with follow-ups of up to 5 years.
The aim of the project will be as following:
- To investigate myocardial pathological features and functional changes in NSTEMI 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 NSTEMI patients.
- To compare myocardial tissue characteristics and functional changes in STEMI (data derived from EARLY-MYO-CMR) and NSTEMI patients.
- To verify GRACE Score classification in NSTEMI from CMR imaging view.
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
- •NSTEMI patients who have had CMR imaging performed and have provided written consent.
- •Patient older than 18 years old with non-ST-segment elevation myocardial infarction (NSTEMI):
- •Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,
- •One of the two following criteria:
- •New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram,
- •Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal,
- •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(MACE)
时间窗: 1 year
次要结局
未报告次要终点