Quality of Life Clinical Trial
— CONTRAST-2Official title:
Assessment of the Effects of Long-term Lipid-lowering Therapy on Parameters of Electrical Myocardial Heterogeneity, Myocardial Deformation Characteristics, Vascular Rigidity, and Quality of Life in Patients With Primary STEMI or NSTEMI
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.N. Burdenko. Recruitment of patients will be carried out at the Department of Therapy of the Medical Institute of the Penza State University. Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study. Initially, lipid-lowering treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy. If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day. Standard AMI treatment includes dual antiplatelet therapy, ACE inhibitors, beta-blockers (if indicated). Prescription of proton pump inhibitors and nitrates is possible (if indicated). The total follow-up is 96 weeks. Prescreening - 600 people; screening and randomization - 300 people. Parameters of electrical myocardial heterogeneity, myocardial deformation characteristics, vascular rigidity, and quality of life will be assessed according to the study plan.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 30, 2027 |
Est. primary completion date | November 12, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | Inclusion Criteria: 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 Criteria: 1. Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG; 2. Recurrent or repeated myocardial infarction. 3. Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia). 4. The development of acute heart failure III-IV prior to randomization 5. Individual intolerance to statins, ezetimibe. 6. Congenital and acquired heart diseases. 7. Severe concomitant diseases in the stage of decompensation. 8. Non-sinus rhythm, established artificial pacemaker. 9. Sinoatrial and atrioventricular blockade of 2-3 degrees. 10. QRS complex exceeding 100 ms. 11. The presence of severe LV hypertrophy according to echocardiography. 12. Uncontrolled hypertension with SBP> 180 mm Hg and DBP> 110 mmHg 13. Diabetes mellitus (DM) type 1 and 2. 14. Current existence of severe anemia (Hb < 100 g/L) 15. Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI). 16. Non-corrected thyroid dysfunction with hyper / hypothyroidism. 17. Body mass index (BMI) =35 kg / m2. 18. Pregnancy, lactation. 19. Alcohol abuse, drug addiction. 20. Other serious concomitant diseases that exclude the possibility of study participation. 21. Participation in other clinical trials within the last two months. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Valentin Oleynikov | Penza |
Lead Sponsor | Collaborator |
---|---|
Penza State University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventricular arrhythmias | Statistically significant differences in the frequency of ventricular arrhythmias as compared to controls | up to 48 months | |
Primary | Systolic function | Statistically significant differences in systolic function of the left ventricle according to transthoracic echocardiography as compared to controls; | up to 48 months | |
Primary | Myocardial deformation of the LA and LV | Statistically significant differences in the myocardial deformation of the LA and LV as compared to controls | up to 48 months | |
Primary | PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina | Statistically significant differences for major coronary events - PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina as compared to controls | up to 48 months | |
Primary | Myocardial electrical instability | Statistically significant differences in the late ventricular potentials, heart rate variability, QT interval dispersion (ms) as compared to controls | up to 120 hours for 2 years period | |
Primary | Heart rate turbulence | Statistically significant differences in the parameters of heart rate turbulence (%) as compared to controls | up to 120 hours for 2 years period | |
Secondary | Cardiovascular mortality | Statistically significant differences for incidence of CV events as compared to controls | up to 48 months | |
Secondary | Frequency of repeated fatal / non-fatal MI | Statistically significant differences in the frequency of repeated fatal / non-fatal MI as compared to controls | up to 48 months | |
Secondary | Hospitalization due to acute decompensation of heart failure | Statistically significant differences according to the frequency of hospitalization due to acute decompensation of heart failure as compared to controls | up to 48 months | |
Secondary | Structural state of arteries different types | Statistically significant differences in pulse wave velocities in arteries of various calibers, as compared to controls | up to 48 months | |
Secondary | Structural state of carotid artery | Statistically significant differences in intima-media thickness of carotid artery according ultrasound, as compared to controls | up to 48 months | |
Secondary | Functional state of arteries | Statistically significant differences in flow-mediated dilation parameters (diameter of brachial artery, mm) assessed by ultrasound, as compared to controls | up to 48 months | |
Secondary | Progression of CHF, exercise tolerance | Statistically significant differences in 6-minute walk test (distance covered, m), as compared to controls | up to 48 months | |
Secondary | Progression of CHF, laboratory data | Statistically significant differences in BNP level (pg/ml), as compared to controls | up to 48 months | |
Secondary | Left ventricular remodeling | Statistically significant differences echocardiographic parameters of left ventricle pathological remodeling (ejection fraction, %, EDVi, ESVi) as compared to controls | up to 48 months | |
Secondary | Lipid profile | Statistically significant differences of lipid profile (mmol/l) as compared to controls | up to 48 months | |
Secondary | Laboratory parameters | Statistically significant differences of CRP (mg/l) as compared to controls | up to 48 months | |
Secondary | Angina episodes | Statistically significant differences on angina episodes assessed by Seattle Angina Questionnaire (min - 19, max - 108 better outcome), as compared to controls | up to 48 months | |
Secondary | Quality of life questionnaire | Statistically significant differences according to the quality of life of patients assessed by Minnesota Questionnaire (min -0, max-105, worse outcome), as compared to controls | up to 48 months | |
Secondary | Quality of life questionnaire in ?HF | Statistically significant differences according to the quality of life of patients assessed by Clinical Assessment Scale for CHF(min -0, max-20, worse outcome), as compared to controls | up to 48 months | |
Secondary | Patients wellbeing | Statistically significant differences of patients wellbeing according to the analog-visual scale , as compared to controls | up to 48 months |
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