Cardiac Computed Tomography for Comprehensive Risk Stratification of Arrhythmic, Atherothrombotic and Heart Failure Events Following Reperfused 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
- 200
- 试验地点
- 6
- 主要终点
- CCT - risk stratification
研究概览
简要总结
The CT-STEMI study aims to evaluate a comprehensive cardiac computed tomography (CCT) protocol for assessing the risk of heart failure (HF), life-threatening arrhythmias (LTA), and atherothrombotic events following ST-elevation myocardial infarction (STEMI). This multicenter, prospective study has three main objectives:
- Comparing the diagnostic accuracy of the comprehensive CCT protocol with cardiac magnetic resonance (CMR), considered the non-invasive gold standard.
- Determining the prognostic value of CCT in assessing myocardial tissue adverse features related to STEMI.
- Evaluating the atherosclerotic burden in patients with post-acute STEMI.
Two hundred patients will undergo both CCT and CMR in the post-acute phase, and their follow-up will focus on monitoring HF, LTA, and ischemic events. The CT-STEMI study represents the first attempt to assess the potential of CCT in providing a comprehensive risk assessment following STEMI in a large contemporary population. The findings of this study have the potential to revolutionize post-STEMI risk stratification practices.
详细描述
Background / State of Art
STEMI remains a leading cause of mortality. In the first year, STEMI survivors face an incident burden of heart failure (HF) as high as 25%, of ischemic events up to 18.3% and of LTA up to 1.5%.
CMR has emerged as the most potent tool to predict adverse left ventricular (LV) remodeling following STEMI. Infarct size (IS), microvascular obstruction (MVO) and intramyocardial hemorrhage (IMH) measured by CMR are all independent HF predictors, able to outperform clinical and reperfusion parameters and to predict long-term adverse remodeling among patients with initially preserved LV ejection fraction (LVEF).
Systematic CMR implementation following STEMI into routine clinical practice is difficult for several reasons, including limited availability, high costs as well as practical issues such as time and staff allocation. Moreover, CMR does not assess the coronary tree failing to provide a risk assessment comprehensive of the atherothrombotic component, beyond HF and arrhythmias.
Since recent advances in CCT technology have expanded its applicability beyond accurate morpho-functional assessment to the characterization of the myocardium, allowing for quantification of IS, MVO and extracellular volume (ECV). CCT may now offer unprecedent opportunities to provide a comprehensive risk assessment following STEMI with an ever-increasing available technology, with moderate costs and logistic effectiveness, and with very low radiation dose exposure with current scanners and protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Signed informed consent
- •STEMI diagnosis
- •Primary Percutaneous Coronary Intervention (PCI) <24h from symptom onset
- •Hemodynamic stability without inotropic support within 4 days from the index event
排除标准
- •Known chronic kidney disease with estimated Glomerular Filtration Rate (GFR) < 30 mL/min/1.73mq
- •History of allergic reaction to CCT or CMR contrast media
- •Inability or unwilling to undergo CCT or CMR scanning
- •Pregnancy or breast-feeding
- •Severe atrial or ventricular arrhythmia burden
- •Severe valvular stenosis or regurgitation
- •Prior clinical congestive HF diagnosis (asymptomatic LV dysfunction can be included)
结局指标
主要结局
CCT - risk stratification
时间窗: 1 month, 1 year
Individual CCT predictors will be evaluated and compared with those derived from CMR: * IS: presence or absence * IS (gr) * IS (% of the total left ventricular mass) * Myocardial edema: presence or absence * Myocardial edema (gr) * Myocardial edema (% of the total left ventricular mass) * MVO: presence or absence * MVO (gr) * MVO (% of the total left ventricular mass) * IMH: presence or absence * IMH (gr) * IMH (% of the total left ventricular mass) * ECV (%)
CCT - diagnostic accuracy
时间窗: Baseline
CMR study will be used as the reference standard to assess the accuracy of CCT in evaluating morpho-functional parameters such as * LVEDV (ml) * LVESV (ml) * LVEF (%) * RVEDV (ml) * RVESV (ml) * RVEF (%) Additionally, the study will also examine myocardial tissue characteristics including: * IS: presence or absence * IS (gr) * IS (% of the total left ventricular mass) * Myocardial edema: presence or absence * Myocardial edema (gr) * Myocardial edema (% of the total left ventricular mass) * MVO: presence or absence * MVO (gr) * MVO (% of the total left ventricular mass) * IMH: presence or absence * IMH (gr) * IMH (% of the total left ventricular mass) * ECV (%)
CCT - Coronary artery disease (CAD) impact of risk stratification
时间窗: Baseline, 1 month, 1 year
CCT Report include prevalence and features of non-culprit plaques with a qualitative analysis, based on the presence of: * positive remodeling: presence or absence * low attenuation plaque: presence or absence * spotty calcification: presence or absence * "napkin ring" sign: presence or absence and semi-quantitative analysis with a dedicated cardiac CT software: * Plaque burden (%) * Plaque volume (per lesion and per vessel) (mm\^3) * Vessel remodeling index (ratio) * Mean plaque and lumen intensities (HU) * Plaque characterization components: presence or absence of Dense Calcium, Necrotic Core, Fibrous Fatty, Fibrous * Evaluation of Peri Vascular Adipose Tissue (PVAT) - thickness measurement in millimeters (mm) * Evaluation of Peri Vascular Adipose Tissue (PVAT) - volume measurement in millimeters cubed (mm\^3) Finally this data will used to investigate the independent predictive significance of CCT-assessed coronary plaque characteristics on event prediction.
次要结局
未报告次要终点
研究者
Marco Gatti
Principal Investigator
University of Turin, Italy