Coronary Physiology Testing in Acute Coronary Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Defining the predictive value of the classification of patients based on coronary physiology
研究概览
简要总结
This is an interventional, prospective, multicenter study (5 IRCCS hospitals belonging to the Italian Cardiology Network) in patients with STEMI treated with successful primary PCI to assess the ability of coronary physiology parameters measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event. Furthermore, patients will be followed up for a period of 12 months to assess the incidence of major adverse cardiovascular events (death, death from cardiovascular causes, re-infarction, new coronary revascularization interventions, development of heart failure) based on their stratification according to coronary physiology parameters.
详细描述
In the present study the investigators will enroll consecutive patients with STEMI acute myocardial infarction treated with successful primary PCI, to assess the ability of coronary physiology parameters, i.e. coronary flow reserve (CFR) and index of microvascular resistance (IMR) measured after recanalization to predict myocardial tissue characterization (MVO, MSI, IS, T2-rt, T1-rt and ECV) assessed with contrast CMR within a week of the acute event. Furthermore, the relationship between left ventricular end-diastolic pressure and of coronary physiology parameters will be evaluated.
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
- •Patients with STEMI (defined according to ESC Guidelines 2017), with symptom onset within 12 hours (Class I), or between 12 and 48 hours (Class IIa), (1) successfully treated with primary PCI. (1)
排除标准
- •Patients with previous myocardial infarction in the territory of the infarct-related artery;
- •Patients with previous coronary artery bypass grafting;
- •Patients with cardiogenic shock at presentation;
- •Patients with need for mechanical support of the circulation;
- •Patients with known severe aortic stenosis / insufficiency;
- •Patients with known cardiomyopathy;
- •Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
- •Patients affected by known active infectious diseases;
- •Women who are pregnant or breastfeeding;
- •Patients who are unable to express valid informed consent upon enrollment;
- •Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);
- •Patients with specific contraindications to cardiac magnetic resonance imaging, including:
- •Patients with allergies and / or with other specific contraindications to the use of paramagnetic contrast media (gadolinium), including chronic renal failure with glomerular filtrate (eGFR) <30 mL / min;
- •Patients with non-resonance-compatible devices or who have undergone previous surgical interventions with placement of non-resonance-compatible vascular clips;
- •Claustrophobic patients.
结局指标
主要结局
Defining the predictive value of the classification of patients based on coronary physiology
时间窗: 5 ± 2 days of the acute event.
Establish the predictive value of the classification of patients based on coronary physiology measured in acute after primary PCI in patients with STEMI, on the incidence of microvascular obstruction (MVO) measured with CMR with contrast medium within 5 ± 2 days of the acute event.
次要结局
未报告次要终点
研究者
Prof. Paolo G Camici MD FACC
Prof Paolo G. Camici MD, FACC
IRCCS San Raffaele