Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intramyocardial haemorrhage in primary STEMI measure
研究概览
简要总结
The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.
详细描述
The study non-randomized, opened, controlled. In half of patients despite on carried in-time reperfusion therapy intramyocardial haemorrhage determined after a long-term period of severe ischemia. Earlier, definition of intramyocardial haemorrhage was possible only by autopsy. Nowaday, cardiac contrast MRI is the best diagnostic method, which allows to assess the regional and global function of the LV, structural changes in myocardial tissue and also in T2 mode it became assessable to reveal intramyocardial haemorrhage.
Taking into account the results of previous researches, it can be concluded that the intramyocardial haemorrhage was determined in half of patients with primary PCI [1]. An influence of fibrinolytic therapy to the intramyocardial haemorrhage was conducted in small group of patients in one trial, and therefore further data will be actual and useful [2].
It is planned to study 60 patients with primary STEMI using standard therapy. The patients will be divided into 2 groups. Patients of the 1st group will be treated by pharmaco-invasive strategy. The 2nd group will be treated by primary PCI. Patients in all groups after reperfusion strategies will be conducted cardiac contrast MRI for detection intramyocardial haemorrhage within 2 days onset. At day 7 and through 3 months, the clinical condition of the patients will be assessed and cardiac ultrasound will be performed for the evaluation of myocardial contractile function and 2D global longitudinal strain. Also, the incidence rate of secondary endpoints will be evaluated.
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
- •Age ≥ 18 years at time of randomization (18 years and older);
- •Acute myocardial infarction;
- •Reperfusion of the infarct-related coronary artery in terms within 12 h of symptom onset;
- •Written the informed consent to participate in research;
排除标准
- •Inability to obtain informed consent;
- •Patients previously undergone endovascular / surgical revascularization of coronary artery;
- •Severe comorbidity;
- •History of myocardial infarction;
- •History of intracranial haemorrhage;
- •Pulmonary edema, cardiogenic shock;
- •Creatinine clearance <30 mL/min or dialysis;
- •Unable to undergo or contra-indications for MRI;
- •Allergy for contrast agent;
- •Indication or use of oral anticoagulant therapy;
- •Major bleedind;
- •Atrio-ventricular block II and III degree;
- •Active gastroduodenal ulcer;
- •Aortic dissection;
- •Acute psychotic disorders
研究组 & 干预措施
Pharmaco-invasive strategy
Fibrinolytic therapy (Streptokinase, Alteplasa, Tenecteplasa in standard dose) is conducted within 12 h of symptom onset in the pre-hospital setting if primary PCI cannot be performed within 120 min from STEMI diagnosis. Then PCI is performed to all of patients.
干预措施: Pharmaco-invasive strategy (Drug)
Primary PCI
Primary percutaneous coronary intervention (PCI) in patients with primary STEMI
干预措施: Primary PCI (Procedure)
结局指标
主要结局
Intramyocardial haemorrhage in primary STEMI measure
时间窗: 2 days
Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion
次要结局
- Mortality measure(3 months)
- Left ventricular ejection fraction (LVEF) recovery measure(3 months (with intermediate measurement at day 7 after reperfusion))
- Global Longitudinal Strain(3 months (with intermediate measurement at day 7 after reperfusion))
- Recurrent myocardial infarction measure(3 months)
- Heart failure incidence measure(3 months)
- Stroke incidence measure(3 months)
- Major bleeding incidence measure(3 months)