Immunometabolic Pattern of Intermittent Hypoxia During ST-segment Elevation Myocardial Infarction
Immunometabolic Pattern of Intermittent Hypoxia as a Protective Mechanism Against Lethal Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Koraljka Benko, MD
- 电话号码:+38598462387
- 邮箱:bkoraljka@yahoo.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Group 1- angina pectoris
Patients with acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);
|
|
无干预:Group 2 - angina pectoris + STEMI+ PCI
Patients with acute myocardial infarction with ST-segment elevation, < 6 hours from the onset of chest pain and preceding symptoms of angina pectoris with primary percutaneous coronary intervention.
|
|
有源比较器:Group 3 - without angina pectoris + STEMi + RIC + PCI
Patients with acute myocardial infarction with ST-segment elevation, < 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention during which it's carried out remote ischemic conditioning (RIC)
|
RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.
|
无干预:Group 4 - without angina pectoris + STEMI + PCI
Patients with acute myocardial infarction with ST-segment elevation, < 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention.
|
|
有源比较器:Group 5 - healthy + RIC
healthy volunteers of the same age and sex, whose samples will be taken after the RIC procedure
|
RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Measurement of the concentration and dynamics of troponin T (Trop T)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of cardiac myosin binding protein C (cMyBP-C)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of creatine kinase-MB (CK-MB)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of oxidation/mitochondrial parameter, hypoxia-induced factor 1 alpha (HIF 1α)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of metabolic parameter, glycine
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of metabolic parameter, kynurenine
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of metabolic parameter, succinate
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of immunological parameter, interleukin 1 beta (IL-1 beta)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of immunological parameter, transforming growth factor beta (TGF beta)
大体时间: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.
|
24 hour
|
Measurement of the concentration and dynamics of immunological parameter, monocyte chemoattraction protein 1 (MCP-1)
大体时间: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.
|
24 hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The changes in serum values of immunometabolic parameters and creatine kinase-MB
大体时间:24 hour
|
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage creatine kinase-MB.
|
24 hour
|
The changes in serum values of immunometabolic parameters and troponin T
大体时间:24 hour
|
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage troponin T
|
24 hour
|
The changes in serum values of immunometabolic parameters and left heart ejection fraction
大体时间:7 day
|
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with functional assessment of the heart muscle, ejection fraction (%).
|
7 day
|
The changes in serum values of immunometabolic parameters in PCI groups and angina pectoris (AP) group
大体时间:24 hour
|
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the data of patients diagnosed with angina pectoris (AP).
|
24 hour
|
The changes in serum values of immunometabolic parameters in PCI groups and the group of healthy volunteers
大体时间:24 hour
|
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the group of healthy volunteers in whom the RIC method was used.
|
24 hour
|
合作者和调查者
调查人员
- 首席研究员:Koraljka Benko, MD、CHC Rijeka; Croatia
出版物和有用的链接
一般刊物
- Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
- Hausenloy DJ. Cardioprotection techniques: preconditioning, postconditioning and remote conditioning (basic science). Curr Pharm Des. 2013;19(25):4544-63. doi: 10.2174/1381612811319250004.
- Han X, Jeong MH, Won J, Kim Y, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Impact of Previous Angina on Clinical Outcomes in ST-Elevation Myocardial Infarction Underwent Percutaneous Coronary Intervention. Chonnam Med J. 2020 May;56(2):136-143. doi: 10.4068/cmj.2020.56.2.136. Epub 2020 May 25.
- Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.