Prognostic Value of Cardiac Magnetic Resonance Parameters in Patients With ST-Segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 主要终点
- Occurrence of Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
This prospective, multicenter observational study aims to evaluate the prognostic value of a comprehensive set of cardiac magnetic resonance (CMR) imaging parameters in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The study integrates advanced artificial intelligence (AI) techniques to extract and analyze high-dimensional imaging features from multiple CMR sequences-including cine, strain mapping, and functional sequences-going beyond traditional measures such as infarct size or microvascular obstruction.
The primary objective is to identify novel prognostic markers from routinely acquired CMR images that reflect myocardial structure, function, and mechanical deformation (strain), and to assess their association with long-term clinical outcomes. In addition to standard parameters, the study includes a detailed evaluation of left and right ventricular systolic and diastolic volumes, ejection fractions, and biventricular strain components (including longitudinal, circumferential, and radial strain), as well as left and right atrial volumes, emptying fractions, and reservoir/conduit/booster strain indices.
Approximately 1000 STEMI patients will undergo CMR scanning within one week after PCI. The imaging data will be subjected to AI-based feature extraction and dimensionality reduction algorithms to uncover latent patterns associated with adverse outcomes. Patients will be followed for up to three years for the occurrence of major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, and heart failure hospitalization.
The central hypothesis is that comprehensive CMR functional and strain-derived parameters, when analyzed using AI-driven models, offer independent and incremental prognostic value beyond conventional clinical risk factors. This study seeks to establish a data-driven, multimodal imaging framework for personalized risk stratification in STEMI patients, potentially enabling more precise post-infarction management strategies.
No investigational treatment is involved. All imaging and clinical data are collected as part of routine care and analyzed retrospectively for outcome prediction.
详细描述
This is a prospective, multicenter observational study designed to investigate the prognostic value of comprehensive cardiac magnetic resonance (CMR) imaging parameters in patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI). The study focuses on leveraging artificial intelligence (AI)-based analysis to extract predictive features from a wide range of standard and advanced CMR sequences, aiming to identify imaging-derived biomarkers that provide independent and incremental value in forecasting long-term cardiovascular outcomes.
Traditional CMR indicators such as infarct size, left ventricular ejection fraction (LVEF), and microvascular obstruction (MVO) have demonstrated utility in post-MI risk stratification. However, these parameters do not fully exploit the wealth of information embedded within the full CMR dataset, especially data reflecting myocardial and atrial mechanics. In this study, we apply advanced computational methods-including radiomics, machine learning, and survival modeling techniques-to analyze multidimensional features extracted from routine, non-contrast CMR sequences.
CMR image acquisition includes short-axis cine imaging and dedicated functional sequences allowing for the quantification of bi-ventricular and bi-atrial function and deformation. Specifically, the following parameters are collected and analyzed:
- Left Ventricular (LV) Parameters LV End-Diastolic Volume (LVEDV) LV End-Systolic Volume (LVESV) LV Stroke Volume (LVSV) LVEF Global Longitudinal Strain (LVGLS) Global Circumferential Strain (LVGCS) Global Radial Strain (LVGRS)
- Right Ventricular (RV) Parameters RVEDV RVESV RVSV RV Mass RVEF RVGLS, RVGCS, RVGRS
- Left Atrial (LA) Parameters Maximum Volume (LAVmax) Pre-Atrial Contraction Volume (LAVpac) Minimum Volume (LAVmini) Total, Passive, and Booster Emptying Fractions (LAEF) Reservoir, Conduit, and Booster Strain
- Right Atrial (RA) Parameters RAVmax RAVpac RAVmini Total, Passive, and Booster RAEF RA Reservoir, Conduit, and Booster Strain All images are analyzed by trained imaging specialists using semi-automated tools (e.g., CVI42) for myocardial and atrial contouring. The left ventricular myocardium is segmented at the end-diastolic phase, and regions of interest (ROIs) are exported for radiomic analysis using ITK-SNAP and PyRadiomics. Preprocessing includes voxel size resampling, normalization, and gray-level discretization.
To ensure reliability and minimize redundancy, feature selection is performed in several stages. First, features with intra- and inter-observer intraclass correlation coefficients (ICC) ≥ 0.75 are retained. Second, highly collinear features are removed using correlation thresholding. Third, feature importance is assessed via random survival forests (RSF), followed by least absolute shrinkage and selection operator (LASSO) Cox regression to construct an optimized feature set. Selected features are used to calculate a radiomics-based risk score (RAD score), which is incorporated into survival models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Diagnosed with ST-segment elevation myocardial infarction (STEMI), defined as chest pain with ST-segment elevation on ECG and elevated cardiac troponin levels
- •Underwent primary percutaneous coronary intervention (PCI)
- •Able to undergo cardiac magnetic resonance (CMR) imaging within 7 days post-PCI
- •Provided written informed consent
排除标准
- •Contraindications to CMR (e.g., severe claustrophobia, implanted cardiac defibrillators or non-compatible pacemakers)
- •History of revascularization therapy (PCI or CABG) within the previous 6 months
- •Severe valvular heart disease or known cardiomyopathy
- •Presence of bundle branch block or fascicular block that interferes with image interpretation
- •Known allergy to gadolinium-based contrast agents (for those undergoing contrast-enhanced sequences)
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (if contrast use is anticipated)
- •Pregnant or breastfeeding women
结局指标
主要结局
Occurrence of Major Adverse Cardiovascular Events (MACE)
时间窗: From the date of CMR imaging to the first occurrence of MACE during follow-up (maximum of 5 years)
Major Adverse Cardiovascular Events (MACE) is defined as a composite outcome including cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure. The occurrence of MACE during follow-up will be used to assess the prognostic value of CMR-derived parameters and AI-based imaging features.
次要结局
未报告次要终点
研究者
XIN A
Dr
Chinese PLA General Hospital