Assessment of the Effects of Long-term Lipid-lowering Therapy on Parameters of Electrical Myocardial Heterogeneity, Myocardial Deformation Characteristics, Vascular Rigidity, and Quality of Life in Patients With Primary STEMI or NSTEMI
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Ventricular arrhythmias
研究概览
简要总结
In a single-center, open-label, prospective, controlled, clinical study, it is planned to include 300 patients hospitalized in the cardiology department of SBHI Penza regional clinical hospital n.a. N.N. Burdenko. Recruitment of patients will be carried out at the Department of Therapy of the Medical Institute of the Penza State University. Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study.
Initially, lipid-lowering treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy.
If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.
Standard AMI treatment includes dual antiplatelet therapy, ACE inhibitors, beta-blockers (if indicated). Prescription of proton pump inhibitors and nitrates is possible (if indicated).
The total follow-up is 96 weeks. Prescreening - 600 people; screening and randomization - 300 people. Parameters of electrical myocardial heterogeneity, myocardial deformation characteristics, vascular rigidity, and quality of life will be assessed according to the study plan.
详细描述
Methods
- Blood chemistry test. Total cholesterol, LDL, HDL, triglycerides, AST, ALT, CPK, glucose, CRP, creatinine, glycosylated hemoglobin
- 2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA). 3D speckle echocardiography (3DSTE) for a detailed study of the phase-by-phase movement and spatial interaction of all muscle layers of the left ventricle in different phases of the cardiac cycle to obtain quantitative values of the deformation of the left ventricle individual segments in the longitudinal, circumferential and radial directions.
The analysis of standard indicators of echocardiography: biplane ejection fraction according to the Simpson method, 3D ejection fraction, EDV (end-diastolic volume), ESV (end-systolic volume) and their indices. The left ventricular myocardial mass index (LVMI).
Using a tissue doppler, the parameters characterizing the diastolic function are recorded: the LA volume, the early diastolic velocity of the mitral valve fibrous ring, the ratio of the early diastolic transmitral flow E to the average early diastolic speed of the fibrous ring e´, and the maximum tricuspid regurgitation rate.
Myocardial strain is analyzed using specialized software - EchoPac Software Only (General Electric Co., 2018). For three-dimensional strain analysis, the left ventricle is automatically divided into 17 segments using standard segmentation schemes. The software allows obtaining strain values in the endocardial, middle and epicardial layers of the myocardium. Over a period of time, indicators for each segment are automatically calculated:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography.
- •Presence of an infarct-related artery according to coronary angiography.
排除标准
- •Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
- •Recurrent or repeated myocardial infarction.
- •Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
- •The development of acute heart failure III-IV prior to randomization
- •Individual intolerance to statins, ezetimibe.
- •Congenital and acquired heart diseases.
- •Severe concomitant diseases in the stage of decompensation.
- •Non-sinus rhythm, established artificial pacemaker.
- •Sinoatrial and atrioventricular blockade of 2-3 degrees.
- •QRS complex exceeding 100 ms.
- •The presence of severe LV hypertrophy according to echocardiography.
- •Uncontrolled hypertension with SBP> 180 mm Hg and DBP> 110 mmHg
- •Diabetes mellitus (DM) type 1 and
- •Current existence of severe anemia (Hb < 100 g/L)
- •Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI).
- •Non-corrected thyroid dysfunction with hyper / hypothyroidism.
- •Body mass index (BMI) ≥35 kg / m
- •Pregnancy, lactation.
- •Alcohol abuse, drug addiction.
- •Other serious concomitant diseases that exclude the possibility of study participation.
- •Participation in other clinical trials within the last two months.
研究组 & 干预措施
Atorvastatin 80 mg
Treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy.
If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.
干预措施: Atorvastatin 80mg (Drug)
Atorvastatin-Ezetimibe
In the absence of reaching the target level of LDL-C of ≤1.4 mmol / L and a decrease in the indicator by ≥50% after 5-6 weeks from the onset of AMI, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.
干预措施: Atorvastatin 80mg (Drug)
结局指标
主要结局
Ventricular arrhythmias
时间窗: up to 48 months
Statistically significant differences in the frequency of ventricular arrhythmias as compared to controls
Myocardial deformation of the LA and LV
时间窗: up to 48 months
Statistically significant differences in the myocardial deformation of the LA and LV as compared to controls
Systolic function
时间窗: up to 48 months
Statistically significant differences in systolic function of the left ventricle according to transthoracic echocardiography as compared to controls;
Myocardial electrical instability
时间窗: up to 120 hours for 2 years period
Statistically significant differences in the late ventricular potentials, heart rate variability, QT interval dispersion (ms) as compared to controls
PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina
时间窗: up to 48 months
Statistically significant differences for major coronary events - PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina as compared to controls
Heart rate turbulence
时间窗: up to 120 hours for 2 years period
Statistically significant differences in the parameters of heart rate turbulence (%) as compared to controls
次要结局
- Frequency of repeated fatal / non-fatal MI(up to 48 months)
- Progression of CHF, exercise tolerance(up to 48 months)
- Progression of CHF, laboratory data(up to 48 months)
- Hospitalization due to acute decompensation of heart failure(up to 48 months)
- Structural state of arteries different types(up to 48 months)
- Functional state of arteries(up to 48 months)
- Left ventricular remodeling(up to 48 months)
- Lipid profile(up to 48 months)
- Patients wellbeing(up to 48 months)
- Laboratory parameters(up to 48 months)
- Cardiovascular mortality(up to 48 months)
- Structural state of carotid artery(up to 48 months)
- Quality of life questionnaire(up to 48 months)
- Angina episodes(up to 48 months)
- Quality of life questionnaire in СHF(up to 48 months)
研究者
Valentin Oleynikov
DM
Penza State University