Effect of 80-mg Atorvastatin on Myocardial Edema
Condition: Myocardial Edema
MeSH terms: Edema
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether atorvastatin 80mg can reduce the
      development of myocardial edema following coronary artery bypass surgery.

      This study also want to determine:

        1. whether atorvastatin 80mg can influence Follistatin-like 1 (FSTL1) plasma level
           following bypass surgery?

        2. whether there is correlation between myocardial edema and FSTL1 plasma level?

        3. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in reducing hs-CRP (high
           sensitive-C reactive protein) and MDA (malondialdehyde) plasma level following bypass
           surgery?

        4. the efficacy of atorvastatin 80mg compared to atorvastatin 10mg in raising PKA and PKB
           plasma level following bypass surgery?
    

Detailed description: 
      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.
    

Intervention name(s): Atorvastatin 80mg; Atorvastatin 10mg
Intervention type(s): Drug; Drug
Intervention description(s): Subject will be given atorvastatin 80mg for two weeks; Subjects will be give atorvastatin 10mg as part of standard therapy in hospital
Other intervention name(s): Lipitor; Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: atorvastatin; myocardial edema; Follistatin-like 1; FSTL1; atorvastatin 80mg; coronary artery bypass surgery