Status:
RECRUITING
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Lead Sponsor:
Penza State University
Conditions:
Myocardial Infarction, Acute
Myocardial Strain
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Methods 1. Blood chemistry test. Total cholesterol, LDL, HDL, triglycerides, AST, ALT, CPK, glucose, CRP, creatinine, glycosylated hemoglobin 2. 2D and 3D transthoracic echocardiography (Vivid GE 95 ...
Eligibility Criteria
Inclusion
- 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
- Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
- Recurrent or repeated myocardial infarction.
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
- The development of acute heart failure III-IV prior to randomization
- Individual intolerance to statins, ezetimibe.
- Congenital and acquired heart diseases.
- Severe concomitant diseases in the stage of decompensation.
- Non-sinus rhythm, established artificial pacemaker.
- Sinoatrial and atrioventricular blockade of 2-3 degrees.
- QRS complex exceeding 100 ms.
- The presence of severe LV hypertrophy according to echocardiography.
- Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg
- Diabetes mellitus (DM) type 1 and 2.
- Current existence of severe anemia (Hb \< 100 g/L)
- Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI).
- Non-corrected thyroid dysfunction with hyper / hypothyroidism.
- Body mass index (BMI) ≥35 kg / m2.
- Pregnancy, lactation.
- Alcohol abuse, drug addiction.
- Other serious concomitant diseases that exclude the possibility of study participation.
- Participation in other clinical trials within the last two months.
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04347434
Start Date
February 12 2020
End Date
December 30 2027
Last Update
November 24 2023
Active Locations (1)
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1
Valentin Oleynikov
Penza, Russia, 440026