SPEctral CT and miRna In Acute Myocardial Infarction for Comprehensive Adverse Remodeling Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Incidence of adverse ventricular remodeling at 6 months, defined as an increase in LV end-diastolic volume ≥20% compared with baseline.
研究概览
简要总结
Acute myocardial infarction with ST-segment elevation (STEMI) remains a leading cause of morbidity and mortality worldwide. Although advances in reperfusion therapy have reduced early mortality, many patients later develop adverse ventricular remodeling (AVR), which increases the risk of heart failure and cardiovascular death. Current imaging methods, such as echocardiography and cardiac magnetic resonance (CMR), provide valuable prognostic information but have limitations in availability, cost, and their ability to predict AVR early and individually.
Spectral computed tomography (CT) is an emerging imaging technique that can characterize myocardial tissue, quantify infarct size, assess microvascular obstruction, and detect complications, with lower contrast and radiation requirements compared to conventional CT. In parallel, circulating microRNAs (miRNAs) have been identified as stable and non-invasive biomarkers that reflect key biological processes in post-infarction remodeling. Several miRNAs are linked to fibrosis, apoptosis, and ventricular remodeling, suggesting their potential to complement imaging findings in risk prediction.
This study proposes a multicenter, prospective cohort of patients with STEMI and reduced left ventricular function to evaluate whether combining spectral CT tissue characterization with serum miRNA profiling can improve early prediction of AVR. The main objective is to generate and validate a multiparametric prognostic model integrating imaging and molecular biomarkers to identify high-risk patients who may benefit from closer monitoring and tailored therapeutic strategies.
详细描述
Background and Rationale Acute myocardial infarction with ST-segment elevation (STEMI) continues to represent a major public health challenge, being one of the leading causes of morbidity and mortality worldwide. Advances in reperfusion therapy, particularly primary percutaneous coronary intervention (PCI), have substantially reduced short-term mortality rates. Nevertheless, a large proportion of patients experience adverse ventricular remodeling (AVR) during follow-up. AVR is characterized by pathological changes in left ventricular (LV) geometry, wall thinning, chamber dilation, and progressive decline in contractile function. These changes are strongly associated with the development of heart failure and increased long-term mortality.
Traditional imaging modalities, such as echocardiography and cardiac magnetic resonance (CMR), have been used to characterize post-infarction myocardial damage and to monitor remodeling. Echocardiography is widely available and provides important functional information, but it lacks the ability to characterize myocardial tissue in depth. CMR is currently the gold standard for infarct size quantification, detection of microvascular obstruction, and assessment of myocardial viability; however, it is costly, time-consuming, and not universally accessible. There remains an unmet need for more accessible, rapid, and accurate tools to predict AVR early after STEMI.
Spectral computed tomography (CT) has recently emerged as an innovative imaging technique that goes beyond conventional CT by providing spectral information and material decomposition. This technology enables enhanced tissue characterization, accurate quantification of myocardial perfusion defects, and identification of complications such as myocardial rupture or thrombus, all while using reduced contrast volume and lower radiation doses compared with older-generation scanners. Preliminary data suggest that spectral CT can approximate some of the information traditionally obtained through CMR, potentially offering a more accessible tool for post-infarction risk stratification.
In parallel, circulating microRNAs (miRNAs) have been identified as highly stable, non-invasive biomarkers involved in key biological processes relevant to cardiac remodeling, including fibrosis, apoptosis, angiogenesis, and inflammatory signaling. Several miRNAs have been associated with infarct size, LV dysfunction, and clinical outcomes in patients with acute myocardial infarction. Integrating molecular biomarkers with imaging could provide a powerful multiparametric model for early prediction of AVR, guiding patient-tailored therapeutic strategies.
The SPECTRAMI-CARE study (SPEctral CT and miRna In Acute Myocardial Infarction for Comprehensive Adverse Remodeling Evaluation) is designed as a prospective, multicenter observational cohort. The protocol aims to evaluate the complementary role of spectral CT and circulating miRNAs in predicting adverse remodeling after STEMI with impaired LV function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adults ≥18 years.
- •First STEMI treated with primary PCI.
- •Left ventricular ejection fraction (LVEF) ≤45% during index hospitalization.
- •Ability to provide informed consent.
排除标准
- •Contraindication to iodinated contrast media.
- •Chronic kidney disease with eGFR <30 mL/min/1.73 m².
- •Prior myocardial infarction or known cardiomyopathy.
- •Contraindication to CT or MRI imaging.
- •Life expectancy <1 year due to non-cardiac conditions.
研究组 & 干预措施
Control group
At the coordinating center (CAUSA), a control group (n = 20) will be included, consisting of patients with a clinical indication for cardiac CT for reasons other than myocardial infarction, meeting the following criteria: absence of myocardial injury or structural heart disease, ≤1 cardiovascular risk factor, LVEF > 55%, and no significant valvular disease (grade < III).
干预措施: Blood analysis and spectral CT study (Procedure)
Adult patients experiencing a first ST-segment elevation myocardial infarction (STEMI)
Patientes will be included in this group if the following requirements are met:
Hospital admission due to STEMI, treated in accordance with current clinical practice guidelines.
Left ventricular systolic dysfunction, defined as a left ventricular ejection fraction (LVEF) < 50%, assessed by transthoracic echocardiography (TTE) within the first 24-72 hours of admission.
Provision of signed informed consent.
干预措施: Blood analysis, spectral CT scan and cardiac magnetic resonance imaging (CMR) study (Procedure)
结局指标
主要结局
Incidence of adverse ventricular remodeling at 6 months, defined as an increase in LV end-diastolic volume ≥20% compared with baseline.
时间窗: 6 months
The primary endpoint will be the occurrence of adverse ventricular remodeling (AVR) as assessed by cardiac magnetic resonance imaging (CMR). AVR will be defined as an increase in left ventricular end-diastolic volume (LVEDV) of ≥20% compared with baseline values obtained during the acute phase (3-7 days post-STEMI). In cases where CMR is not feasible, spectral CT-derived LV volumes will be used as a contingency reference, given their validated correlation with CMR measurements.
次要结局
- Major adverse cardiovascular events (MACE)(From baseline to 6 months)
- Infarct size characterization by spectral CT vs. CMR.(Baseline and 6 months)
- Myocardial characterization by spectral CT vs. CMR.(Baseline and 6 months)
- Correlation of miRNA signatures with remodeling.(Baseline and 6 months)
- Predictive accuracy of integrated models (spectral CT + miRNA vs. conventional predictors)(6 months)
- Safety outcomes: incidence of contrast-induced nephropathy(From baseline to 6 months)
- Safety outcomes: allergic or hypersensitivity reactions(From baseline to 6 months)
- Safety outcomes: arrhythmias related to imaging procedures(From baseline to 6 months)
- Safety outcomes: Cumulative radiation exposure(From baseline to 6 months)