Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19 : Evaluation of Long-term Lipid-lowering Therapy on Myocardial Electrical Heterogeneity, Myocardial Deformation, Arterial Stiffness and Quality of Life in Patients With Primary STEMI/NSTEMI With Coronavirus Infection COVID-19
It is planned to include 200 patients hospitalized in the cardiology department of the "Penza Regional Clinical hospital Burdenko" with a STEMI diagnosis in combination with COVID-19. Patients with STEMI and NSTEMI will be included in the study within the first 15 days from the disease onset. The total follow-up period is 96 weeks.Primary goals:achieving the target level of low-density lipoprotein cholesterol (LDL-C) on the background of lipid-lowering therapy as monotherapy with atorvastatin or combined treatment with atorvastatin plus ezetimibe;decrease in the incidence of major coronary events - percutaneous coronary interventions (PCI) / coronary artery bypass surgery (CABG) for a new case of coronary atherosclerosis, hospitalization for unstable angina or recurrent myocardial infarction;reduction of the frequency of life-threatening arrhythmias and markers of the risk of sudden cardiac death according to the data of long-term ECG monitoring;increase in myocardial contractility by improving the deformation characteristics of the peri-infarction zone.Secondary goals:Assess the effect of long-term effective lipid-lowering therapy:indicators of global and regional myocardial deformation, depending on the degree of of coronary blood flow restoration according to TIMI scale;systolic and diastolic LV function in the presence of initial disturbances or the absence of negative dynamics of these indicators with normal initial values;on clinical and diagnostic criteria for the development or progression of heart failure (HF);on the dynamics of myocardial ischemia episodes according to the data of long-term electrocardiography (ECG) monitoring;for the immediate and long-term prognosis of patients;on the structural and functional properties of large arteries.Assess the dynamics of biochemical parameters against the background of double and monotherapy with lipid-lowering drugs.Assess the safety of treatment.Assess the impact on the patient's well-being and quality of life.Assess therapy complianceConduct a comparative analysis of the prognostic value of markers of myocardial electrical heterogeneity, obtained from the data of long-term and 24-hour ECG monitoring.To determine the effect of markers of electrical instability and autonomic regulation of cardiac activity, obtained during long-term ECG monitoring in patients at different times after myocardial infarction, on the short-term and long-term prognosis.Development of a multivariate model that takes into account the parameters of electrophysiological heterogeneity and the main indicators of the cardiovascular system condition (data of echocardiography, blood vessels ultrasound, laboratory test), which allows predicting the development of repeated cardiac events.Methods and variablesOffice blood pressure12-lead ECGCoronary angiography. Percutaneous coronary interventionChemistry blood test The lipid profile: total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C), non-HDL. Alanine aminotransferase (ALT), aspartat aminotransferase (AST), creatine phosphokinase (CPK), glucose, C-reactive protein (CRP), brain natriuretic peptide (BNP), serum creatinine and glomerular filtration rate (CKD-EPI), troponin I/T, CPK-MB, ferritin, sodium, potassium, lactate, procalcitonin, D-dimer, coagulogram. Nasopharyngeal swab for SARS-CoV-2 to RNA by PCR, if necessary - additional determination of immunoglobulins to SARS-CoV-2.2D and 3D transthoracic echocardiography is performed with Vivid GE 95 Healthcare (USA). The biplane ejection fraction is determined by the Simpson method, 3D ejection fraction, EDV (end-diastolic volume), ESV (end-systolic volume) and their indexed parameters in 2D and 3D mode. Left ventricular myocardial mass index (LVMI), LA volume. Myocardial deformity is analyzed using specialized software - EchoPac Software Only (General Electric Co., 2018)Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability.Ultrasound of common carotid arteries using high-frequency RF signal technology will be carried out in B-mode on the MyLab 90 device (Esaote, Italy) by the following indicators: IMT - thickness of the intima-media, loc Psys - local systolic pressure in the carotid artery, loc Pdia - local diastolic pressure, P (T1) - pressure at a local point, stiffness indices β and α, DC - coefficient transverse distensibility, CC - transverse compliance coefficient, Aix - augmentation index, AR - amplification pressure, PWV - local pulse wave velocity in the carotid artery.Applanation tonometry The SphygmoCor device (AtCor Medical, Australia) includes two software. The first allows to record indicators of central aortic pressure: systolic aortic pressure - SBPao, diastolic - DBPao, pulse pressure - PPao, mean hemodynamic pressure - MBPao. The PWV (pulse wave velocity) software is used to analyze the PWV in the aorta (cfPWV).Assessment of the arterial stiffness by volume sphygmography. PWV in the aorta (PWV), in elastic arteries right and left (R/L-PWV) and in muscular arteries (B-PWV), Cardio-Ankle Vascular Index - CAVI.Flow-mediated vasodilation6-minute walk testComputer pulse oximetry (PulseOx 7500 (SPO medical, Israel)Adherence to Treatment: Counting remaining pills and completing the Morisky-Green QuestionnaireAssessment of quality of life: Seattle Angina Questionnaire (SAQ), Minnesota LIGE with Heart Failure Questionnaire, Clinical Status Assessment Scale (CASA), analog-visual scale.Assessment of physical activity International Questionnaire On Physical Activity - IPAQHospital Anxiety and Depression Scale (HADS)Endpoint assessment The end point is understood as the development of repeated AMI, unstable angina pectoris, PCI for a new atherosclerotic plaque, hospitalization due to chronic heart failure (CHF) exacerbation, the development of a new case of CHF II-IV NYHA class, death..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
ClinicalTrials.gov - (2023) vom: 24. Nov. Zur Gesamtaufnahme - year:2023 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: May 25, 2021, Last downloaded: ClinicalTrials.gov processed this data on November 29, 2023, Last updated: November 29, 2023 |
|---|
| Study ID: |
NCT04900155 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG007672020 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG007672020 | ||
| 003 | DE-627 | ||
| 005 | 20231129010415.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210603s2023 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG007672020 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT04900155 | ||
| 035 | |a (UBBS_Klinische_Studien)PSU/T-487 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19 |b Evaluation of Long-term Lipid-lowering Therapy on Myocardial Electrical Heterogeneity, Myocardial Deformation, Arterial Stiffness and Quality of Life in Patients With Primary STEMI/NSTEMI With Coronavirus Infection COVID-19 |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: May 25, 2021, Last downloaded: ClinicalTrials.gov processed this data on November 29, 2023, Last updated: November 29, 2023 | ||
| 520 | |a It is planned to include 200 patients hospitalized in the cardiology department of the "Penza Regional Clinical hospital Burdenko" with a STEMI diagnosis in combination with COVID-19. Patients with STEMI and NSTEMI will be included in the study within the first 15 days from the disease onset. The total follow-up period is 96 weeks.Primary goals:achieving the target level of low-density lipoprotein cholesterol (LDL-C) on the background of lipid-lowering therapy as monotherapy with atorvastatin or combined treatment with atorvastatin plus ezetimibe;decrease in the incidence of major coronary events - percutaneous coronary interventions (PCI) / coronary artery bypass surgery (CABG) for a new case of coronary atherosclerosis, hospitalization for unstable angina or recurrent myocardial infarction;reduction of the frequency of life-threatening arrhythmias and markers of the risk of sudden cardiac death according to the data of long-term ECG monitoring;increase in myocardial contractility by improving the deformation characteristics of the peri-infarction zone.Secondary goals:Assess the effect of long-term effective lipid-lowering therapy:indicators of global and regional myocardial deformation, depending on the degree of of coronary blood flow restoration according to TIMI scale;systolic and diastolic LV function in the presence of initial disturbances or the absence of negative dynamics of these indicators with normal initial values;on clinical and diagnostic criteria for the development or progression of heart failure (HF);on the dynamics of myocardial ischemia episodes according to the data of long-term electrocardiography (ECG) monitoring;for the immediate and long-term prognosis of patients;on the structural and functional properties of large arteries.Assess the dynamics of biochemical parameters against the background of double and monotherapy with lipid-lowering drugs.Assess the safety of treatment.Assess the impact on the patient's well-being and quality of life.Assess therapy complianceConduct a comparative analysis of the prognostic value of markers of myocardial electrical heterogeneity, obtained from the data of long-term and 24-hour ECG monitoring.To determine the effect of markers of electrical instability and autonomic regulation of cardiac activity, obtained during long-term ECG monitoring in patients at different times after myocardial infarction, on the short-term and long-term prognosis.Development of a multivariate model that takes into account the parameters of electrophysiological heterogeneity and the main indicators of the cardiovascular system condition (data of echocardiography, blood vessels ultrasound, laboratory test), which allows predicting the development of repeated cardiac events.Methods and variablesOffice blood pressure12-lead ECGCoronary angiography. Percutaneous coronary interventionChemistry blood test The lipid profile: total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C), non-HDL. Alanine aminotransferase (ALT), aspartat aminotransferase (AST), creatine phosphokinase (CPK), glucose, C-reactive protein (CRP), brain natriuretic peptide (BNP), serum creatinine and glomerular filtration rate (CKD-EPI), troponin I/T, CPK-MB, ferritin, sodium, potassium, lactate, procalcitonin, D-dimer, coagulogram. Nasopharyngeal swab for SARS-CoV-2 to RNA by PCR, if necessary - additional determination of immunoglobulins to SARS-CoV-2.2D and 3D transthoracic echocardiography is performed with Vivid GE 95 Healthcare (USA). The biplane ejection fraction is determined by the Simpson method, 3D ejection fraction, EDV (end-diastolic volume), ESV (end-systolic volume) and their indexed parameters in 2D and 3D mode. Left ventricular myocardial mass index (LVMI), LA volume. Myocardial deformity is analyzed using specialized software - EchoPac Software Only (General Electric Co., 2018)Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability.Ultrasound of common carotid arteries using high-frequency RF signal technology will be carried out in B-mode on the MyLab 90 device (Esaote, Italy) by the following indicators: IMT - thickness of the intima-media, loc Psys - local systolic pressure in the carotid artery, loc Pdia - local diastolic pressure, P (T1) - pressure at a local point, stiffness indices β and α, DC - coefficient transverse distensibility, CC - transverse compliance coefficient, Aix - augmentation index, AR - amplification pressure, PWV - local pulse wave velocity in the carotid artery.Applanation tonometry The SphygmoCor device (AtCor Medical, Australia) includes two software. The first allows to record indicators of central aortic pressure: systolic aortic pressure - SBPao, diastolic - DBPao, pulse pressure - PPao, mean hemodynamic pressure - MBPao. The PWV (pulse wave velocity) software is used to analyze the PWV in the aorta (cfPWV).Assessment of the arterial stiffness by volume sphygmography. PWV in the aorta (PWV), in elastic arteries right and left (R/L-PWV) and in muscular arteries (B-PWV), Cardio-Ankle Vascular Index - CAVI.Flow-mediated vasodilation6-minute walk testComputer pulse oximetry (PulseOx 7500 (SPO medical, Israel)Adherence to Treatment: Counting remaining pills and completing the Morisky-Green QuestionnaireAssessment of quality of life: Seattle Angina Questionnaire (SAQ), Minnesota LIGE with Heart Failure Questionnaire, Clinical Status Assessment Scale (CASA), analog-visual scale.Assessment of physical activity International Questionnaire On Physical Activity - IPAQHospital Anxiety and Depression Scale (HADS)Endpoint assessment The end point is understood as the development of repeated AMI, unstable angina pectoris, PCI for a new atherosclerotic plaque, hospitalization due to chronic heart failure (CHF) exacerbation, the development of a new case of CHF II-IV NYHA class, death. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Coronavirus Infections | |
| 650 | 2 | |a ST Elevation Myocardial Infarction | |
| 650 | 2 | |a Non-ST Elevated Myocardial Infarction | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2023) vom: 24. Nov. |
| 773 | 1 | 8 | |g year:2023 |g day:24 |g month:11 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT04900155 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 951 | |a AR | ||
| 952 | |j 2023 |b 24 |c 11 | ||