Assessment of the Effects of Atorvastatin Therapy on Myocardial Deformation Characteristics, in Patients With STEMI
Status:
Completed
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
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.