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

PSU/T-471

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.

2020-02-12

2027-11-12

2027-12-30

Recruiting

Early phase I

300

Inclusion Criteria: 1. Signed Informed Consent Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography. 3. Presence of an infarct-related artery according to coronary angiography. Exclusion Criteria: 1. Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG; 2. Recurrent or repeated myocardial infarction. 3. Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia). 4. The development of acute heart failure III-IV prior to randomization 5. Individual intolerance to statins, ezetimibe. 6. Congenital and acquired heart diseases. 7. Severe concomitant diseases in the stage of decompensation. 8. Non-sinus rhythm, established artificial pacemaker. 9. Sinoatrial and atrioventricular blockade of 2-3 degrees. 10. QRS complex exceeding 100 ms. 11. The presence of severe LV hypertrophy according to echocardiography. 12. Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg 13. Diabetes mellitus (DM) type 1 and 2. 14. Current existence of severe anemia (Hb \< 100 g/L) 15. Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI). 16. Non-corrected thyroid dysfunction with hyper / hypothyroidism. 17. Body mass index (BMI) ≥35 kg / m2. 18. Pregnancy, lactation. 19. Alcohol abuse, drug addiction. 20. Other serious concomitant diseases that exclude the possibility of study participation. 21. Participation in other clinical trials within the last two months.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of AMI in addition to standard therapy for the disease.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-11-24