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

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)

Conditions

• STEMI
• Covid19
• NSTEMI

Interventions

DRUG

Atorvastatin 80mg

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-Ezetimibe

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.

Sponsors & Collaborators

• Penza State University

  lead OTHER

Principal Investigators

• Valentin Oleynikov · Penza State University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-20

Primary Completion

2024-11-30

Completion

2024-12-31

Countries

• Russia

Study Locations