Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04347434
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT04347434
Study Brief:
Protocol Section:
NCT04347434