Tissue Characterization in ST-Segment Elevation Myocardial Infarction: A Multicenter Registry of Patients Evaluated With Cardiac Magnetic Resonance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Incidence of MACE (Major Adverse Cardiac Events)
研究概览
简要总结
This multicenter registry includes patients with a first ST-segment elevation myocardial infarction (STEMI) who underwent cardiac magnetic resonance (CMR) imaging during the acute phase and follow-up. The registry is designed to identify clinical and CMR-derived predictors of adverse ventricular remodeling and major adverse cardiac events (MACE). CMR provides accurate and reproducible assessment of infarct size, left ventricular function, microvascular obstruction, and tissue characteristics, enabling detailed prognostic modeling.
详细描述
Adverse left ventricular remodeling after STEMI is a key determinant of long-term morbidity and mortality. Although primary PCI and guideline-directed therapies have improved outcomes, 10-15% of patients still develop adverse remodeling and heart failure. CMR enables precise measurement of infarct size, left ventricular volumes, ejection fraction, microvascular obstruction, and tissue parameters (T1, extracellular volume), which may enhance risk stratification compared with other imaging techniques.
The registry is based on harmonized clinical and imaging datasets from three experienced centers in Spain, forming a large repository of standardized variables. This structure facilitates the identification of predictors of infarct size, ventricular remodeling, and major adverse cardiac events (MACE), and provides a framework for the development of improved prognostic models and the exploration of potential therapeutic targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •First STEMI evaluated within the first 24 hours of symptom onset
- •At least one CMR performed during the acute phase
- •Signed informed consent (for prospective patients) or previous consent (for retrospective inclusion).
排除标准
- •Severe renal failure (GFR < 30 ml/min)
- •STEMI > 24 hours after symptom onset
- •Contraindications to CMR (e.g., claustrophobia, hemodynamic instability, non-MR-compatible devices, vascular clips)
- •Pregnancy or breastfeeding.
结局指标
主要结局
Incidence of MACE (Major Adverse Cardiac Events)
时间窗: From hospital discharge (or index CMR) to at least 6 months, with extended follow-up planned for as long as 5 years, subject to data availability.
The primary endpoint is the occurrence of MACE during follow-up. MACE is defined as a composite of the following events: Cardiac death (death attributable to cardiovascular causes) Heart failure hospitalization (unplanned admission with a primary diagnosis of heart failure) Heart transplantation or durable mechanical circulatory support Appropriate ICD therapy (appropriate shock or anti-tachycardia pacing for ventricular arrhythmia in patients with implantable defibrillators). The occurrence of the first event in the composite will be used for time-to-event analyses. The first event in the composite will be used for time-to-event analyses. Event classification will be determined according to standardized definitions and based on review of available medical records.
次要结局
未报告次要终点