Effects of long-term lipid-lowering therapy in heart attack patients

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

This study is testing if a long-term treatment with atorvastatin can help heart attack patients lower their cholesterol and improve their heart health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 30 Years to 70 Years
• Sex: All
• Sponsor: Penza State University (other)
• Locations: 1 site (Penza)
• Trial ID: NCT04347434 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of long-term lipid-lowering therapy using atorvastatin in patients who have experienced primary STEMI or NSTEMI. The study involves administering atorvastatin at a dose of 80 mg per day within the first few days of acute myocardial infarction, followed by ezetimibe if LDL cholesterol levels are not adequately reduced. Patients will undergo various assessments, including blood tests and advanced echocardiography, to monitor heart function and lipid levels over time. The goal is to determine the effectiveness of this treatment approach in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals who have recently suffered a primary STEMI or NSTEMI and meet specific inclusion criteria.

Not a fit: Patients with severe coronary artery disease or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve heart health and quality of life for patients recovering from heart attacks.

How similar studies have performed: Previous studies have shown positive outcomes with lipid-lowering therapies in similar patient populations, suggesting a promising approach.

Eligibility criteria

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.

Where this trial is running

Penza

• Valentin Oleynikov — Penza, Russia (RECRUITING)

Study contacts

• Principal investigator: Valentin E Oleynikov, DM — Penza State University
• Study coordinator: Nadezhda V Burko, PhD

Conditions: Myocardial Infarction, Acute, Myocardial Strain, Arterial Stiffness, Quality of Life, STEMI, NSTEMI, myocardial strain,, arterial stiffness,