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

NCT04900155 | Unknown

• 1 other identifier: PSU/T-487
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.
3. 3.Office blood pressure
4. 4.12-lead ECG
5. 5.Coronary angiography. Percutaneous coronary intervention
6. 6.Chemistry blood test
7. 7.2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA)
8. 8.Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability.
9. 9.Ultrasound of common carotid arteries using high-frequency radio-frequency signal technology
10. 10.Applanation tonometry (SphygmoCor, AtCor, Australia)
11. 11.Assessment of the arterial stiffness by volume sphygmography.
12. 12.Flow-mediated vasodilation
13. 13.Six-minute walk test
14. 14.Computer pulse oximetry (PulseOx 7500 (SPO medical, Israel)
15. 15.Adherence to Treatment: Counting remaining pills and completing the Morisky-Green Questionnaire
16. 16.Assessment of quality of life
17. 17.Assessment of physical activity: International Questionnaire On Physical Activity - IPAQ
18. 18.Hospital Anxiety and Depression Scale (HADS)

Conditions

STEMI; Covid19; NSTEMI

Keywords

myocardial strain; arterial stiffness; myocardial electrical heterogeneity; quality of life

Outcome Measures

Primary Outcomes (6)

• Lipid profile assessment

  Achievement of target level of lipid profile (total cholesterol, LDL-С, HDL-C, triglycerides) during the atorvastatin therapy

  up to 96 weeks

• Assessment of ventricular rhythm disturbances

  The frequency of ventricular arrhythmias recorded with 24 hour ECG monitoring

  up to 96 weeks

• Electrical instability and autonomic regulation of heart rate

  Changes in parameters of electrical instability and autonomic regulation of heart rate recorded with 24 hour ECG monitoring

  up to 96 weeks

• Left ventricular systolic function

  Assessment of LV systolic function differences according to echocardiography during atorvastatin treatment

  up to 96 weeks

• Left ventricular myocardial deformation (strain, strain rate)

  Assessment of LV myocardial deformation (strain, strain rate) differences according to echocardiography during atorvastatin treatment

  up to 96 weeks

• Number of Participants with major cardiovascular events

  Number of Participants with major cardiovascular events: PCI / CABG for a new case of coronary atherosclerosis, hospitalizations for unstable angina pectoris, recurrent AMI

  up to 96 weeks

Study Arms (2)

Atorvastatin 80 mg

ACTIVE COMPARATOR

Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of myocardial infarction in addition to standard therapy for the disease.

Drug: Atorvastatin 80mg

Atorvastatin-Ezetimibe

ACTIVE COMPARATOR

In the absence of reaching the target level of LDL-C ≤1.4 mmol / L and ≥50% of the initial level after 4-6 weeks from the onset of myocardial infarction, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.

Drug: Atorvastatin-Ezetimibe

Interventions

Atorvastatin 80mg DRUG

Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of myocardial infarction in addition to standard therapy for the disease.

Also known as: Atorvastatin

Atorvastatin 80 mg

Atorvastatin-Ezetimibe DRUG

In the absence of reaching the target level of LDL-C ≤1.4 mmol / L and ≥50% of the initial level after 4-6 weeks from the onset of myocardial infarction, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.

Also known as: Atorvastatin

Atorvastatin-Ezetimibe

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Patients of both genders aged 30 to 70 years
• The presence of one of the options for a combination of confirmed myocardial infarction and new coronavirus infection:
• 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.
• Development of a confirmed case of COVID-19 within 30 days from the myocardial infarction onset.
• 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.
• 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.
• 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.
• 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):
• 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.

You may not qualify if:

• Hemodynamically significant stenosis of the left coronary artery\> 30%.
• Recurrent or repeated STEMI or NSTEMI.
• Exogenous hypertriglyceridemia (type 1 hyperchylomicronemia - TC / TG \<0.15).
• Acute heart failure III-IV.
• Individual intolerance to statins, ezetimibe, alirocumab.
• Congenital and acquired heart defects.
• Non-sinus rhythm, artificial pacemaker.
• Sinoatrial and atrioventricular block of 2-3 degrees.
• QRS complex\> 100 ms.
• Complete blockade of left or right bundle branch.
• History of CHF III-IV class according to NYHA.
• The presence of pronounced LV hypertrophy according to echocardiography (IVS / LVS\> 14 mm).
• Uncontrolled hypertension with SBP\> 180 mm Hg. and DBP\> 110 mm Hg.
• Diabetes mellitus type 1 or type 2 requiring insulin therapy.
• Presence of anemia at the time of screening (Hb \<100 g / l)

Sponsors & Collaborators

• Penza State University: lead

Study Sites (1)

Valentin Oleynikov

Penza, 440026, Russia

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; COVID-19; Non-ST Elevated Myocardial Infarction

Interventions

Atorvastatin; liptruzet

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Valentin Oleynikov

  Penza State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Therapy Department

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 25, 2021
• Study Start: November 20, 2020
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

RU (1)