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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penza State University
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

1. Signed Informed Consent Form

2. Patients having physical and mental ability to participate in the study

3. Patients of both sexes aged 35 to 65 years

4. Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels.

5. Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%.

Exclusion Criteria:

1. A history of repeat or recurrent myocardial infarction;

2. A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA);

3. Presence of left ventricular hypertrophy confirmed by echocardiography;

4. QRS complex exceeding 1.0;

5. Ejection fraction less than 40%;

6. Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;

7. Type 1 diabetes mellitus;

8. Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin;

9. Any severe concurrent disease;

10. A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study;

11. Active hepatic disease or liver enzyme elevation of unclear etiology more than 3 times higher than the upper limit of normal;

12. Hepatic failure or bilirubin elevation more than 1.5 times higher than the upper limit of normal;

13. Uncontrolled arterial hypertension (AH), with systolic blood pressure (SBP) exceeding 180 mm Hg and diastolic blood pressure (DBP) exceeding 110 mm Hg;

14. A history of heart rhythm and/or cardiac conduction disorder;

15. Inborn and/or acquired heart defects;

16. A history of aortic aneurysm;

17. Current existence of severe anemia (Hb < 100 g/L);

18. Chronic renal disease (creatinine clearance < 30 mL/min);

19. Uncorrected thyroid dysfunction, with hyper- or hypothyroidism;

20. Intolerance of statins;

21. Alcohol abuse and drug use;

22. Participation in other clinical studies within the last two months.