Immunometabolic Pattern of Intermittent Hypoxia as a Protective Mechanism Against Lethal Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 主要终点
- Measurement of the concentration and dynamics of metabolic parameter, kynurenine
研究概览
简要总结
The aim of this study is to characterize the protective pattern of intermittent hypoxia, angina pectoris and remote ischemic conditioning, in reperfusion injury by determining and monitoring the plasma immunometabolic parameters of patients with STEMI. This could contribute to better understanding of this phenotypic pattern with translation into clinical practice.
详细描述
In acute myocardial infarction with ST segment elevation (STEMI), lethal reperfusion injury of the myocardium, caused by percutaneous coronary intervention (PCI), represents additional and irreversible damage due to ischemic heart muscle reperfusion that contributes to the final size of the infarct zone by up to 50%. The size of the infarcted area is the major determinant for the long-term prognosis and heart failure progression in patients with STEMI. Cardioprotection from ischemic - reperfusion myocardial injury (MIRI) can be regulated by its own innate physiological adaptive mechanisms like intermittent hypoxia achieved by the method of conditioning that includes short sublethal ischemic and reperfusion episodes.
The known natural clinical equivalent of intermittent hypoxia and the starting point in understanding the underlying mechanism is angina pectoris (AP).
Intermittent hypoxia is a protective mechanism against heart ischemic-reperfusion injury with reduced tissue damage and consequently better outcome in patients with STEMI. For the purpose of this work, a cardioprotective pattern was defined that includes immunometabolic factors as parameters for assessing the state of intermittent hypoxia on which the success of the application of the method of remote ischemic conditioning (RIC) is based.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For group 1:
- •Acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);
- •Monovascular disease, preocclusive stenosis with TIMI(thrombolysis in myocardial infarction) > 1 on the left main or anterior descending branch of the left coronary artery
- •Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm
- •For group 2:
- •Acute myocardial infarction with ST-segment elevation (ST-segment elevation> 0.1 mV in two or more leads, or> 0.2 mV in V1-V3) <6 hours from the onset of chest pain
- •Symptoms of angina pectoris preceding acute myocardial infarction
- •Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI <1 flow in STEMI;
- •After opening the artery and setting the stent TIMI> 2 flow
- •Visually estimated epicardial coronary artery diameter up to 2.5 mm to 4.0 mm
- •For groups 3 and 4:
- •Acute myocardial infarction with ST-segment elevation (ST-segment elevation> 0.1 mV in two or more leads, or> 0.2 mV in V1-V3) <6 hours from the onset of chest pain
- •No symptoms of angina pectoris preceding acute myocardial infarction
- •Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI <1 flow in STEMI;
- •After opening the artery and stent placement TIMI> 2 flow
- •Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm
- •For all groups:
- •Age of patients over 18 years
- •Signed written informed consent to be included in the survey
排除标准
- •Cardiac arrest before or after PCI;
- •Cardiogenic shock;
- •Previous myocardial infarction or revascularization of the heart;
- •Anginal pain before the onset of STEMI in patients to be subjected to RIC;
- •Patients with end-stage renal or hepatic disease, diabetics with developed micro and macrovascular complications, oncology patients;
- •Significant collaterals in the area of the occluded artery (Rentrop gradus> 1);
- •Previous use of nitrates and corticosteroids;
- •Pregnant or breastfeeding women;
- •Iodine allergy (contrast media);
- •Increase in body temperature > 37.5 ° C
- •Participation in another clinical trial
- •Randomly selected (coin toss) patients will be randomized to group 3 and 4, respectively, for percutaneous coronary intervention with or without RIC
结局指标
主要结局
Measurement of the concentration and dynamics of metabolic parameter, kynurenine
时间窗: 24 hour
Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of cardiac myosin binding protein C (cMyBP-C)
时间窗: 24 hour
Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of metabolic parameter, glycine
时间窗: 24 hour
Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of immunological parameter, transforming growth factor beta (TGF beta)
时间窗: 24 hour
Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of troponin T (Trop T)
时间窗: 24 hour
Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of metabolic parameter, succinate
时间窗: 24 hour
Serum concentrations (μM) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of immunological parameter, interleukin 1 beta (IL-1 beta)
时间窗: 24 hour
Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of creatine kinase-MB (CK-MB)
时间窗: 24 hour
Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of oxidation/mitochondrial parameter, hypoxia-induced factor 1 alpha (HIF 1α)
时间窗: 24 hour
serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
Measurement of the concentration and dynamics of immunological parameter, monocyte chemoattraction protein 1 (MCP-1)
时间窗: 24 hour
Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.
次要结局
- The changes in serum values of immunometabolic parameters in PCI groups and angina pectoris (AP) group(24 hour)
- The changes in serum values of immunometabolic parameters and creatine kinase-MB(24 hour)
- The changes in serum values of immunometabolic parameters and troponin T(24 hour)
- The changes in serum values of immunometabolic parameters and left heart ejection fraction(7 day)
- The changes in serum values of immunometabolic parameters in PCI groups and the group of healthy volunteers(24 hour)
研究者
Koraljka Benko
M.D.
Clinical Hospital Center Rijeka