Effect of 80-mg Atorvastatin on Myocardial Edema
Ключови думи
Резюме
Описание
This study is an double blinded experimental study using parallel design. Study subjects are patients in Harapan Kita hospital who are registered to CABG (Coronary Artery Bypass Graft) surgery and fulfill all the eligibility criteria.
The subjects will be first consecutively selected, with male age 40-65 as the criteria. After that the investigators do the randomization with block randomization method. All the subjects will be given drug with label A and label B (only the pharmacist know the which dose of atorvastatin belong to which label).
Total subjects needed for this study are 30 (15 belong to study group and 15 belong to control group) MRI (Magnetic Resonance Imaging) results will be read by two radiologists, and analyzed using cronbach alpha. The results are considered equal if the cronbach >0,7. If it is proven to be unequal, then the third radiologist will decide.
Statin is known to have several adverse effects, such as myopathy, myositis to rhabdomyolysis, elevated liver enzyme, memory loss, GI (gastrointestinal) disturbance, and severa others. Therefore, the investigators will check baseline CK (creatine kinase) and liver enzyme at the beginning of the study, before the surgery, and if the patient feel any symptoms. Statin will be stopped if patient decide to stop, or if there is increase in ALT (alanine aminotransferase) higher that three time upper normal value, or if there is increase in CK higher than ten times upper normal value.
Statistical analysis using IBM SPSS statistics version 21.0. Comparative analysis for variables such as smoking history, obesity, hypertension, dyslipidemia, diabetes, family history, infarct history, ACE-I/ARB (angiotensin converting enzyme inihibitor /angiotensin receptor blocker) therapy will be using chi-square or fischer. Comparative analysis for variables T2 relaxation time, FSTL1, hs-CRP, PKA (protein kinase A), PKB (Protein Kinase B), MDA, age, CPB (Cardiopulmonary Bypass) time, CABG time will using unpaired t-test or Mann-whitney. Correlative analysis between FSTL1 and T2 relaxation time will be using Pearson test.
Дати
| Последна проверка: | 07/31/2018 |
| Първо изпратено: | 09/05/2016 |
| Очаквано записване подадено: | 09/13/2016 |
| Първо публикувано: | 09/14/2016 |
| Изпратена последна актуализация: | 08/21/2018 |
| Последна актуализация публикувана: | 08/22/2018 |
| Действителна начална дата на проучването: | 09/30/2016 |
| Приблизителна дата на първично завършване: | 07/31/2018 |
| Очаквана дата на завършване на проучването: | 07/31/2018 |
Състояние или заболяване
Интервенция / лечение
Drug: Atorvastatin 80mg
Drug: Atorvastatin 10mg
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Atorvastatin 80mg Subjects who will receive atorvastatin 80mg for two weeks | Drug: Atorvastatin 80mg Subject will be given atorvastatin 80mg for two weeks |
| Active Comparator: Atorvastatin 10mg Subject who will receive atorvastatin 10mg | Drug: Atorvastatin 10mg Subjects will be give atorvastatin 10mg as part of standard therapy in hospital |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 40 Years Да се 40 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Patients with coronary artery disease indicated for CABG surgery - has signed informed consent Exclusion Criteria: - high risk EURO (European System for Cardiac Operative Risk Evaluation) score - creatinin value>2 g/dl - direct bilirubin value >3 mg/ml - AST/ALT (aspartate transaminase / alanine transaminase) value >1,5 times UNL (upper normal limit) - high pre-operative CKMB (Creatine Kinase-MB) and troponin - LVEF (Left Ventricular Ejection Fraction) <45% - concomitant valve disease required surgery - contraindicated for MRI - high degree ventricular arrhytmia - coagulation disorder - COPD (chronic obsructive pulmonary disease) - HIV (Human Immunodeficiency Virus) +, HBV (Hepatitis B Virus)+, HCV (Hepatitis C Virus) + - conduction abnormality, pacemaker - electrolyte or blood gas disturbance - receiving immunosuppressive drug or cytotoxic agent 4 weeks before surgery - receiving macrolide, azole antifungal, fibrate, or protease inhibitor HIV drug |
Резултат
Първични изходни мерки
1. T2 relaxation time [day 6 after CABG]
Вторични изходни мерки
1. FSTL1 plasma level [day 6 after CABG]
2. PKA plasma level [day 6 after CABG]
3. PKB plasma level [day 6 after CABG]
4. hs-CRP plasma level [day 1 after CABG]
5. MDA plasma level [day 1 after CABG]
6. Change from baseline FSTL1 plasma level [day 1 and day 6 after CABG]
7. Change from baseline PKA plasma level [day 1 and day 6 after CABG]
8. Change from baseline PKB plasma level [day 1 and day 6 after CABG]
