Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

It is planned to include 200 patients hospitalized with primary myocardial infarction with and without ST segment elevation (STEMI or NSTEMI) in combination with COVID-19 within the first 15 days from the disease onset. The total follow-up period is 96 weeks.

Hypotheses:

1. An integrated approach in assessing myocardial contractility, regulation of the heart and the structural and functional state of arteries will make it possible to more accurately assess the heart pumping function; explain the mechanisms of the relationship between left ventricular (LV) contractile function and its volumetric indices; to study the mechanisms of ventriculo-arterial coupling and the influence of autonomic regulation, the role of markers of the sudden cardiac death (late ventricular potentials, pathological turbulence of the heart rate, dispersion of the QT interval).

2. In patients who have had myocardial infarction in combination with the new coronavirus infection SARS-CoV-2 (COVID-19), long-term highly effective lipid-lowering therapy, regardless of the drugs prescribed, has an antiarrhythmic effect and has a beneficial effect on the autonomic regulation of the heart rate. Highly effective lipid-lowering therapy leads to an improvement in LV contractility and structural and functional properties of the large arteries.

Methods and variables

1. Office blood pressure

2. 12-lead ECG

3. Coronary angiography. Percutaneous coronary intervention

4. Chemistry blood test

5. 2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA)

6. Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability.

7. Ultrasound of common carotid arteries using high-frequency radio-frequency signal technology

8. Applanation tonometry (SphygmoCor, AtCor, Australia)

9. Assessment of the arterial stiffness by volume sphygmography.

10. Flow-mediated vasodilation

11. Six-minute walk test

12. Computer pulse oximetry (PulseOx 7500 (SPO medical, Israel)

13. Adherence to Treatment: Counting remaining pills and completing the Morisky-Green Questionnaire

14. Assessment of quality of life

15. Assessment of physical activity: International Questionnaire On Physical Activity - IPAQ

16. Hospital Anxiety and Depression Scale (HADS)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Patients of both genders aged 30 to 70 years

3. The presence of one of the options for a combination of confirmed myocardial infarction and new coronavirus infection:

3.1. Myocardial infarction that developed within 30 days from the onset of COVID-19 - in case of mild to moderate course or within 60 days - in case of severe course.

3.2. Development of a confirmed case of COVID-19 within 30 days from the myocardial infarction onset.

4.1. Clinical manifestations of acute respiratory infection (body t> 37.5 ° C and one or more signs: cough, dry or moist sputum, shortness of breath, chest tightness, SpO2 ≤ 95%, sore throat, mild or moderate rhinorrhea, impaired or loss of smell (hyposmia or anosmia), loss of taste (dysgeusia), conjunctivitis, weakness, muscle pain, headache, vomiting, diarrhea, skin rash) in the presence of at least one of the epidemiological signs:

• returning from a foreign trip 14 days before the onset of symptoms;

• having close contacts in the last 14 days with a person under surveillance for COVID-19 who subsequently fell ill;

• having close contacts in the last 14 days with a person with a laboratory confirmed diagnosis of COVID-19;

• having professional contacts with people who have a suspected or confirmed case of COVID-19.

4.2. The presence of clinical manifestations specified in 4.1, in combination with changes in the lungs according to computed tomography data, regardless of the results of a single laboratory study for the presence of SARS-CoV-2 RNA and an epidemiological history, or if it is impossible to conduct a laboratory study for the presence of SARS-RNA CoV-2.

4.3. A positive laboratory test result for the presence of SARS-CoV-2 RNA using nucleic acid amplification methods (NAA) or SARS-CoV-2 antigen using immunochromatographic analysis, regardless of clinical manifestations.

4.4. Positive result for IgA or IgM, or IgM with IgG in patients with clinically confirmed COVID-19 infection.

Primary STEMI or NSTEMI, confirmed by a diagnostically significant increase in cardiospecific enzymes (5.1) in combination with at least one criterion of acute myocardial ischemia (item 5.2):

5.1. An increase and / or decrease of serum cardiac troponin level, which should at least once exceed the 99th percentile of the URL in patients without an initial increase of serum cardiac troponin level, or its increase> 20% with an initially increased level of cardiac troponin, if up to it remained stable (variation < 20%) or declined.

5.2. Typical anginal attack / acute ischemic changes on the ECG / the appearance of pathological Q waves on the ECG / EchoCG confirmation of the presence of new areas of the myocardium with impaired local contractility / detection of intracoronary thrombosis in coronary angiography.

Presence of type 1 myocardial infarction (6.1) or type 2 (6.2), confirmed by coronary angiography:

6.1. Atherothrombosis of an infarct-related artery with a sharp decrease in blood flow distal to the damaged atherosclerotic plaque or distal embolization with thrombotic masses / fragments of atherosclerotic plaque, followed by the development of myocardial necrosis; or intramural hematoma in a damaged atherosclerotic plaque with a rapid increase in its volume and a decrease in the lumen of the artery).

6.2. Myocardial infarction developed as a result of ischemia caused by non-thrombotic complications of coronary atherosclerosis. Pathophysiologically, such myocardial infarctions are associated with an increase in myocardial oxygen demand and / or a decrease in its delivery to the myocardium, for example, due to coronary artery embolism, spontaneous coronary artery dissection, respiratory failure, anemia, cardiac arrhythmias, arterial hypertension or hypotension, etc.

Duration of subsequent hospitalization after inclusion in the study - at least 5 days

Exclusion Criteria:

1. Hemodynamically significant stenosis of the left coronary artery> 30%.

2. Recurrent or repeated STEMI or NSTEMI.

3. Exogenous hypertriglyceridemia (type 1 hyperchylomicronemia - TC / TG <0.15).

4. Acute heart failure III-IV.

5. Individual intolerance to statins, ezetimibe, alirocumab.

6. Congenital and acquired heart defects.

7. Non-sinus rhythm, artificial pacemaker.

8. Sinoatrial and atrioventricular block of 2-3 degrees.

9. QRS complex> 100 ms.

10. Complete blockade of left or right bundle branch.

11. History of CHF III-IV class according to NYHA.

12. The presence of pronounced LV hypertrophy according to echocardiography (IVS / LVS> 14 mm).

13. Uncontrolled hypertension with SBP> 180 mm Hg. and DBP> 110 mm Hg.

14. Diabetes mellitus type 1 or type 2 requiring insulin therapy.

15. Presence of anemia at the time of screening (Hb <100 g / l)

16. Chronic kidney disease (GFR < 30 ml / min / 1.73 m2 according to the CKD-EPI formula).

17. Uncorrected thyroid dysfunction in the presence of hyper- / hypothyroidism.

18. Body mass index (BMI) ≥35 kg / m2.

19. Pregnancy, lactation.

20. Alcohol abuse, drug use.

21. Other severe concomitant diseases that exclude the possibility of participation in the study.

22. Participation in other clinical trials within the previous 2 months.