Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in LV end-diastolic volumes index, %
研究概览
简要总结
The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.
详细描述
It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.
The study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
- •ST-elevation Q wave myocardial infarction
- •term admission to an intensive care unit (ICU) in the first 24 hours of onset
- •the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
- •written the informed consent to participate in research
排除标准
- •atrial fibrillation, a permanent form
- •valvular heart disease
- •severe comorbidity
- •acute heart failure according to the Killip classification IV FC (functional class)
- •history of chronic heart failure (NYHA III-IV)
- •poor image quality for Echocardiography
- •sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS > 0,11 s.) and atrioventricular block II-III degree
研究组 & 干预措施
Doxycycline
100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy
干预措施: Doxycycline (Drug)
Active comparator
Standard care for STEMI
干预措施: Standard care for STEMI (Other)
结局指标
主要结局
Changes in LV end-diastolic volumes index, %
时间窗: 14 days and 6 month after STEMI
次要结局
- Incidence of the angina,%(14 days and 6 month after STEMI)
- Incidence of cardiovascular death,%(14 days and 6 month after STEMI)
- Incidence of the recurrent myocardial infarction,%(14 days and 6 month after STEMI)
- Incidence of the heart failure,%(14 days and 6 month after STEMI)
- Incidence of the stroke,%(14 days and 6 month after STEMI)
- Changes in 2 D global longitudinals strain,Δ %(14 days and 6 month after STEMI)
- Changes in MMPs and their inhibitors, other biomarkers, pg/ml(14 days and 6 month after STEMI)
- Incidence and severity of adverse events,%(14 days and 6 month after STEMI)
- Incidence of the combined endpoint,%(14 days and 6 month after STEMI)
研究者
Vyacheslav Ryabov
MD, PhD Research Institute for Cardiology
Russian Academy of Medical Sciences