ST-segment Elevation Myocardial Infarction
Conditions
Keywords
Statin, remodeling, STEMI
Brief summary
STEMI is a serious type of coronary heart disease, which is a major cause of disability and death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast proliferation leading to myocardial fibrosis . Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating inflammation and oxidative processes. Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate ventricular remodeling, and protect the myocardium
Detailed description
1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital. 4. Serum samples will be collected from patients at the time of admission for measuring the biomarkers. 5. Echocardiogram also will be obtained at the time of admission. 6. All enrolled patients will be divided into two group to receive either Atorvastatin (40 mg) or Rosuvastatin (20mg). 7. All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers and Echocardiogram will be repeated. 8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. Results, conclusion, discussion, and recommendations will be given.
Interventions
patients will receive one tablet rosuvastatin 20 mg every night
patients will receive one tablet Atorvastatin 40 mg every night
Sponsors
Alexandria University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Electrocardiogram showed abnormal elevation of the ST segment. 2. First myocardial infarction occurred. 3. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.
Exclusion criteria
1. Severe cardiac insufficiency. 2. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level). 3. Renal insufficiency (creatinine clearance rate \<30 mL/min). 4. Addition of others blood lipid lowering and antioxidant drugs during follow up period. 5. Familial hypercholesterolemia. 6. Malignant tumor. 7. Immune system disease. 8. Acute infectious disease. 9. Hypersensitivity to rosuvastatin and Atorvastatin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effect on ventricular remodeling | 3 months | MMP9,sST2 and CRP level will be measured and monitoring the change in their levels Echocardiogram will be obtained and monitoring the change in echocardiogram indexes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effect on lipid parameters and liver enzymes | 3 months | lipid parameters and liver enzymes level will be measured and monitoring the change in their levels |
Countries
Egypt
Outcome results
None listed