Myocardial Edema Clinical Trial
Official title:
Effect of 80-mg Atorvastatin on Myocardial Edema Following Coronary Artery Bypass Surgery in Relation With Follistatin-Like Protein-1
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?
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01059214 -
Cardiac MRI for Patients Enrolled in INFUSE-AMI
|
||
| Recruiting |
NCT03531151 -
MRI of Myocardial Infarction
|