Track topics on Twitter Track topics that are important to you
The primary goal
• To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;
The secondary goals. To evaluate the effect of treatment:
- on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;
- on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)
- on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;
- on the clinical diagnostic criteria for the development or progression of heart failure;
- the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;
- the appearance of new prognostically significant cardiac arrhythmias
- on the pulse wave velocity
- the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of "Therapy" of Medical Institute of Penza State University.
Definition of the study group:
The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study
- Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;
- Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.
Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.
1. Atorvastatin therapy directly results in improved deformation characteristics of hibernating myocardium due to its pleiotropic effects on endothelial dysfunction and atherosclerotic plaque stability, as well as stimulation of angiogenesis in ischemic zones of myocardium.
2. Long-term atorvastatin therapy improves the morphofunctional properties of large arteries and decreases the severity of endothelial dysfunction in patients with a history of myocardial infarction.
3. Atorvastatin causes an anti-ischemic effect, if used for a long time. 2.1. Primary objective To evaluate the effect of atorvastatin, when started between 24 and 96 hours after disease onset, on the parameters of global and regional myocardial deformation in the zone of infarction, as well as morphofunctional properties of arteries, on Day 7 and Weeks 12, 24, 36 and 48 of the treatment; 2.2. Secondary objectives. To evaluate:
- the effect of treatment on the parameters of global and regional myocardial deformation in the zone of intact myocardium on Day 7 and Weeks 12, 24, 36 and 48 of the treatment;
- the effect of treatment on the parameters of global and regional myocardial deformation depending on TIMI blood flow grade;
- the effect of treatment on systolic and diastolic function of the left ventricle in patients with impaired left ventricular function at baseline, as well as the ability of this treatment to prevent deterioration of left ventricular function in patients with normal left ventricular function at baseline;
- the effect of treatment on heart failure development and progression as assessed using the corresponding clinical diagnostic criteria;
- the effect of treatment on duration and time course of myocardial ischemia using 24 hour ECG monitoring on Day 7 and Weeks 12, 24, 36 and 48 of treatment;
- the effect of treatment on the appearance of new prognostically significant disorders of cardiac rhythm;
- the effect of treatment on pulse wave velocity and cardio-ankle vascular index (CAVI);
- the effect of treatment on intima-media thickness (IMT);
- the effect of treatment on the results of automated quantitative vascular elasticity measurements, pulse wave and pulse pressure;
- the effect of treatment on endothelial function using the reactive hyperemia test;
- the effect of treatment on the time course of blood chemistry parameters (i.e., total cholesterol, HDL, LDL, triglycerides, creatinine, C-reactive protein (CRP), alanine transaminase (ALT), aspartate transaminase (AST) and creatinkinase (CK);
- the safety of treatment;
- the effect of treatment on patient's well-being and quality of life;
- patient compliance with the therapy. 2.3. Scientific novelty of the study It is planned to study, for the first time, the effect of long-term aggressive statin therapy on the functional status of myocardium in the zone of ischemia, lesion and necrosis in patients with STEMI using the two-dimensional strain procedure.
It is planned, for the first time, to comprehensively study the effect of aggressive statin therapy on the status of vasculature, with measuring multiple parameters characterizing the morphofunctional status of elastic and muscular arteries in patients with documented coronary heart disease (CHD).
2.4. Clinical significance of study results. If the proposed hypotheses are confirmed after the primary endpoints described in Section 3 have been reached, new convincing evidence supporting the use of long-term aggressive treatment with Atorvastatin starting from the early stages of myocardial infarction will be obtained. Obviously, the clinical benefits will include the improved prognosis and decreased risk of repeated vascular events. Favorable effects of this therapy on the morphofunctional status of arterial vasculature will play an important role in the treatment of these patients. Positive results of this study can form the basis for planning and conducting larger studies on pleiotropic effects of Atorvastatin in patients with a history of myocardial infarction.
3. Primary endpoints
1. Statistically significant differences in spatial and velocity parameters of myocardial deformation in the zone of previous STEMI as compared to controls.
2. Statistically significant differences in spatial and velocity parameters of myocardial deformation in the intact zone after STEMI as compared to controls.
3. Statistically significant differences in intima-media thickness (IMT) according to echo tracking data as compared to controls.
4. Statistically significant differences in carotid-femoral pulse wave velocity and CAVI as compared to controls.
4. Planning and conducting the study. It is planned to include 200 patients in this randomized, open-label, single-center, prospective, controlled clinical study; these patients will be recruited at the Department of Therapy of the Penza State University Medical Institute.
4.1. Allocation to study groups:
Patients with STEMI will be included in this study:
Group 1: 100 patients with STEMI to receive atorvastatin at a dose of 80 mg per day for 48 weeks; Group 2: 100 patients with STEMI to receive atorvastatin at a dose of 20 mg per day for 48 weeks.
4.2. Planned number of patients: Prescreening - 300 patients; screening and randomization - 200 patients.
4.3. Study design. Patients will be randomized using sealed envelopes numbered with increasing serial numbers from 1 to 200; each envelope will contain information about patient inclusion into Group 1 or Group 2. Information about treatment schedule and dosing regimen will be provided separately.
4.3.1. Treatment regimen, dose titration strategy and combination treatment principles Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study.
Group A patients will start the treatment between 24 and 96 hours after the onset of STEMI:
• Atorvastatin at a dose of 80 mg per day.
Group K patients will start the treatment between 24 and 96 hours after the onset of STEMI:
• Atorvastatin at a dose of 20 mg per day.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Penza State University
Published on BioPortfolio: 2015-10-29T14:53:24-0400
The purpose of this study is to determine if oral atorvastatin administered just before percutaneous coronary angioplasty for acute myocardial infarction improves early and late heart func...
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Ato...
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patien...
Phase IV investigator initiated clinical trial to study the effectiveness of alirocumab, an inhibitor of proprotein convertase subtilisin/kexin (PCSK9), versus placebo added to high-intens...
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chro...
Many clinical and experimental studies have shown that treatment with statins could prevent myocardial hypertrophy and remodeling induced by hypertension and myocardial infarction. But the molecular m...
To investigate the effect of different doses of atorvastatin on patients with acute ST segment elevation myocardial infarction (MI) after emergency percutaneous coronary intervention (PCI).
The authors analyzed data from the Hungarian Myocardial Infarction Registry (HUMIR) to examine the potential impact of gender on the treatment and 30-day and 1-year mortality of patients with myocardi...
First, describe how acute myocardial infarction criteria are used to diagnose type 1 (T1MI) and 2 (T2MI) myocardial infarction. Second, determine whether subjective or objective criteria are used for ...
The intensity of the inflammatory response and hemodynamic repercussion in acute myocardial infarction causing the presence in the peripheral circulation of nucleated red blood cells (NRBCs), increase...
MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.
A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction).
A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).
MYOCARDIAL INFARCTION in which the inferior wall of the heart is involved. It is often caused by occlusion of the right coronary artery.
Laceration or tearing of cardiac tissues appearing after MYOCARDIAL INFARCTION.
Lipitor was the best selling drug in 2009, with the 2009 annual sales coming in at over $5m for its company, Pfizer Inc. Lipitor is the brand name for an atorvastatin calcium medication that is prescribed to lower cholesterol and triglycerides in the the...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...