NCT04900155进行中（未招募）不适用
Evaluation of Long-term Lipid-lowering Therapy on Myocardial Electrical Heterogeneity, Myocardial Deformation, Arterial Stiffness and Quality of Life in Patients With Primary STEMI/NSTEMI With Coronavirus Infection COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Electrical instability and autonomic regulation of heart rate
研究概览
简要总结
It is planned to include 200 patients hospitalized with primary myocardial infarction with and without ST segment elevation (STEMI or NSTEMI) in combination with COVID-19 within the first 15 days from the disease onset. The total follow-up period is 96 weeks.
Hypotheses:
- An integrated approach in assessing myocardial contractility, regulation of the heart and the structural and functional state of arteries will make it possible to more accurately assess the heart pumping function; explain the mechanisms of the relationship between left ventricular (LV) contractile function and its volumetric indices; to study the mechanisms of ventriculo-arterial coupling and the influence of autonomic regulation, the role of markers of the sudden cardiac death (late ventricular potentials, pathological turbulence of the heart rate, dispersion of the QT interval).
- In patients who have had myocardial infarction in combination with the new coronavirus infection SARS-CoV-2 (COVID-19), long-term highly effective lipid-lowering therapy, regardless of the drugs prescribed, has an antiarrhythmic effect and has a beneficial effect on the autonomic regulation of the heart rate. Highly effective lipid-lowering therapy leads to an improvement in LV contractility and structural and functional properties of the large arteries.
Methods and variables
- Office blood pressure
- 12-lead ECG
- Coronary angiography. Percutaneous coronary intervention
- Chemistry blood test
- 2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA)
- Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability.
- Ultrasound of common carotid arteries using high-frequency radio-frequency signal technology
- Applanation tonometry (SphygmoCor, AtCor, Australia)
- Assessment of the arterial stiffness by volume sphygmography.
- Flow-mediated vasodilation
- Six-minute walk test
- Computer pulse oximetry (PulseOx 7500 (SPO medical, Israel)
- Adherence to Treatment: Counting remaining pills and completing the Morisky-Green Questionnaire
- Assessment of quality of life
- Assessment of physical activity: International Questionnaire On Physical Activity - IPAQ
- Hospital Anxiety and Depression Scale (HADS)
详细描述
It is planned to include 200 patients hospitalized in the cardiology department of the "Penza Regional Clinical hospital Burdenko" with a STEMI diagnosis in combination with COVID-19. Patients with STEMI and NSTEMI will be included in the study within the first 15 days from the disease onset. The total follow-up period is 96 weeks.
Primary goals:
- achieving the target level of low-density lipoprotein cholesterol (LDL-C) on the background of lipid-lowering therapy as monotherapy with atorvastatin or combined treatment with atorvastatin plus ezetimibe;
- decrease in the incidence of major coronary events - percutaneous coronary interventions (PCI) / coronary artery bypass surgery (CABG) for a new case of coronary atherosclerosis, hospitalization for unstable angina or recurrent myocardial infarction;
- reduction of the frequency of life-threatening arrhythmias and markers of the risk of sudden cardiac death according to the data of long-term ECG monitoring;
- increase in myocardial contractility by improving the deformation characteristics of the peri-infarction zone.
Secondary goals:
- Assess the effect of long-term effective lipid-lowering therapy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients of both genders aged 30 to 70 years
- •The presence of one of the options for a combination of confirmed myocardial infarction and new coronavirus infection:
- •Myocardial infarction that developed within 30 days from the onset of COVID-19 - in case of mild to moderate course or within 60 days - in case of severe course.
- •Development of a confirmed case of COVID-19 within 30 days from the myocardial infarction onset.
- •Clinical manifestations of acute respiratory infection (body t> 37.5 ° C and one or more signs: cough, dry or moist sputum, shortness of breath, chest tightness, SpO2 ≤ 95%, sore throat, mild or moderate rhinorrhea, impaired or loss of smell (hyposmia or anosmia), loss of taste (dysgeusia), conjunctivitis, weakness, muscle pain, headache, vomiting, diarrhea, skin rash) in the presence of at least one of the epidemiological signs:
- •returning from a foreign trip 14 days before the onset of symptoms;
- •having close contacts in the last 14 days with a person under surveillance for COVID-19 who subsequently fell ill;
- •having close contacts in the last 14 days with a person with a laboratory confirmed diagnosis of COVID-19;
- •having professional contacts with people who have a suspected or confirmed case of COVID-
- •The presence of clinical manifestations specified in 4.1, in combination with changes in the lungs according to computed tomography data, regardless of the results of a single laboratory study for the presence of SARS-CoV-2 RNA and an epidemiological history, or if it is impossible to conduct a laboratory study for the presence of SARS-RNA CoV-
- •A positive laboratory test result for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods (NAA) or SARS-CoV-2 antigen using immunochromatographic analysis, regardless of clinical manifestations.
- •Positive result for IgA or IgM, or IgM with IgG in patients with clinically confirmed COVID-19 infection.
- •Primary STEMI or NSTEMI, confirmed by a diagnostically significant increase in cardiospecific enzymes (5.1) in combination with at least one criterion of acute myocardial ischemia (item 5.2):
- •An increase and / or decrease of serum cardiac troponin level, which should at least once exceed the 99th percentile of the URL in patients without an initial increase of serum cardiac troponin level, or its increase> 20% with an initially increased level of cardiac troponin, if up to it remained stable (variation < 20%) or declined.
- •Typical anginal attack / acute ischemic changes on the ECG / the appearance of pathological Q waves on the ECG / EchoCG confirmation of the presence of new areas of the myocardium with impaired local contractility / detection of intracoronary thrombosis in coronary angiography.
- •Presence of type 1 myocardial infarction (6.1) or type 2 (6.2), confirmed by coronary angiography:
- •Atherothrombosis of an infarct-related artery with a sharp decrease in blood flow distal to the damaged atherosclerotic plaque or distal embolization with thrombotic masses / fragments of atherosclerotic plaque, followed by the development of myocardial necrosis; or intramural hematoma in a damaged atherosclerotic plaque with a rapid increase in its volume and a decrease in the lumen of the artery).
- •Myocardial infarction developed as a result of ischemia caused by non-thrombotic complications of coronary atherosclerosis. Pathophysiologically, such myocardial infarctions are associated with an increase in myocardial oxygen demand and / or a decrease in its delivery to the myocardium, for example, due to coronary artery embolism, spontaneous coronary artery dissection, respiratory failure, anemia, cardiac arrhythmias, arterial hypertension or hypotension, etc.
- •Duration of subsequent hospitalization after inclusion in the study - at least 5 days
排除标准
- •Hemodynamically significant stenosis of the left coronary artery> 30%.
- •Recurrent or repeated STEMI or NSTEMI.
- •Exogenous hypertriglyceridemia (type 1 hyperchylomicronemia - TC / TG <0.15).
- •Acute heart failure III-IV.
- •Individual intolerance to statins, ezetimibe, alirocumab.
- •Congenital and acquired heart defects.
- •Non-sinus rhythm, artificial pacemaker.
- •Sinoatrial and atrioventricular block of 2-3 degrees.
- •QRS complex> 100 ms.
- •Complete blockade of left or right bundle branch.
- •History of CHF III-IV class according to NYHA.
- •The presence of pronounced LV hypertrophy according to echocardiography (IVS / LVS> 14 mm).
- •Uncontrolled hypertension with SBP> 180 mm Hg. and DBP> 110 mm Hg.
- •Diabetes mellitus type 1 or type 2 requiring insulin therapy.
- •Presence of anemia at the time of screening (Hb <100 g / l)
- •Chronic kidney disease (GFR < 30 ml / min / 1.73 m2 according to the CKD-EPI formula).
- •Uncorrected thyroid dysfunction in the presence of hyper- / hypothyroidism.
- •Body mass index (BMI) ≥35 kg / m
- •Pregnancy, lactation.
- •Alcohol abuse, drug use.
- •Other severe concomitant diseases that exclude the possibility of participation in the study.
- •Participation in other clinical trials within the previous 2 months.
研究组 & 干预措施
Atorvastatin 80 mg
Active Comparator
Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of myocardial infarction in addition to standard therapy for the disease.
干预措施: Atorvastatin 80mg (Drug)
Atorvastatin-Ezetimibe
Active Comparator
In the absence of reaching the target level of LDL-C ≤1.4 mmol / L and ≥50% of the initial level after 4-6 weeks from the onset of myocardial infarction, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.
干预措施: Atorvastatin-Ezetimibe (Drug)
结局指标
主要结局
Electrical instability and autonomic regulation of heart rate
时间窗: up to 96 weeks
Changes in parameters of electrical instability and autonomic regulation of heart rate recorded with 24 hour ECG monitoring
Left ventricular myocardial deformation (strain, strain rate)
时间窗: up to 96 weeks
Assessment of LV myocardial deformation (strain, strain rate) differences according to echocardiography during atorvastatin treatment
Number of Participants with major cardiovascular events
时间窗: up to 96 weeks
Number of Participants with major cardiovascular events: PCI / CABG for a new case of coronary atherosclerosis, hospitalizations for unstable angina pectoris, recurrent AMI
Left ventricular systolic function
时间窗: up to 96 weeks
Assessment of LV systolic function differences according to echocardiography during atorvastatin treatment
Lipid profile assessment
时间窗: up to 96 weeks
Achievement of target level of lipid profile (total cholesterol, LDL-С, HDL-C, triglycerides) during the atorvastatin therapy
Assessment of ventricular rhythm disturbances
时间窗: up to 96 weeks
The frequency of ventricular arrhythmias recorded with 24 hour ECG monitoring
次要结局
未报告次要终点
研究者
Valentin Oleynikov
Head of Therapy Department
Penza State University
研究点 (1)
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