Actively Recruiting
Assessment of the Effects of Long-term Lipid-lowering Therapy on Electrical Myocardial Heterogeneity, Myocardial Deformation, Vascular Rigidity, and Quality of Life in Patients With Primary STEMI or NSTEMI
Led by Penza State University · Updated on 2023-11-24
300
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of long-term lipid-lowering therapy in patients who have experienced a primary ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI). This study, conducted at a single center, plans to include 300 hospitalized patients meeting specific criteria. The research aims to assess various heart and vascular functions, including electrical myocardial heterogeneity, myocardial deformation, vascular stiffness, and quality of life over an extended period. Participants initially receive atorvastatin at a dose of 80 mg daily within 24 to 96 hours after acute myocardial infarction (AMI) alongside standard therapy, which may include dual antiplatelet therapy, ACE inhibitors, beta-blockers, and other medications as needed. If LDL cholesterol levels do not reach target thresholds after 5-6 weeks, ezetimibe 10 mg once daily is added. The study follows patients for a total of 96 weeks, monitoring changes and responses to treatment. During the study, participants undergo detailed assessments including blood tests, advanced echocardiography to evaluate heart muscle movement, long-term ECG monitoring for heart rhythm and electrical stability, ultrasound of arteries to assess stiffness and structure, and flow-mediated dilation tests for endothelial function. Functional tests like the six-minute walk and pulse oximetry are performed. Quality of life, anxiety, depression, physical activity, and treatment adherence are also evaluated through questionnaires. The primary outcomes include measures of ventricular arrhythmias, heart function, myocardial deformation, and electrical instability over up to 48 months, with additional monitoring of cardiovascular events and quality of life.
CONDITIONS
Brief Title
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Diagnosis of primary STEMI or NSTEMI confirmed by ECG, troponin I, CPK-MB levels, and coronary angiography
- Presence of an infarct-related artery confirmed by coronary angiography
- Age between 30 and 70 years
You will not qualify if you...
- Hemodynamically relevant stenosis exceeding 30% in multiple coronary arteries confirmed by coronary angiography
- Recurrent or repeated myocardial infarction
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia)
- Acute heart failure stage III-IV before randomization
- Individual intolerance to statins or ezetimibe
- Congenital or acquired heart diseases
- Severe decompensated concomitant diseases
- Non-sinus heart rhythm or presence of an artificial pacemaker
- Sinoatrial or atrioventricular block of 2nd or 3rd degree
- QRS complex duration exceeding 100 ms
- Severe left ventricular hypertrophy per echocardiography
- Uncontrolled hypertension with systolic BP > 180 mm Hg or diastolic BP > 110 mm Hg
- Type 1 or 2 diabetes mellitus
- Severe anemia with hemoglobin < 100 g/L
- Chronic kidney disease with creatinine clearance < 30 ml/min/1.73 m2
- Untreated thyroid dysfunction (hyper- or hypothyroidism)
- Body mass index ≥ 35 kg/m2
- Pregnancy or lactation
- Alcohol or drug addiction
- Other serious diseases preventing study participation
- Participation in other clinical trials within the last two months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants receive atorvastatin 80 mg daily starting within 24 to 96 hours after their myocardial infarction, with possible addition of ezetimibe after 5 to 6 weeks if lipid targets are not met.
Regular visits for treatment monitoring and assessments over the treatment period
Duration - Up to 48 months
Participants undergo long-term monitoring of cardiac function, vascular health, and quality of life up to 48 months after treatment initiation, including repeated assessments such as echocardiography, ECG monitoring, ultrasound scans, physical activity tests, and questionnaires.
Periodic visits for assessments and monitoring as scheduled throughout the study
Trial Site Locations
Total: 1 location
1
Valentin Oleynikov
Penza, Russia, 440026
Actively Recruiting
Research Team
N
Nadezhda V Burko, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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