Randomized Control Parallel Trial on the Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Interventio
Not Applicable
- Conditions
- Patients with Ischemic Heart Disease Undergoing PCI
- Registration Number
- JPRN-UMIN000002576
- Lead Sponsor
- Ogaki Municipal Hospital,department of cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Patients with acute myocardial infarction with ST segment elevation (2)Patients with non–ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography (3) Patients with increased plasma liver enzymes(AST or ALT >= 100 IU/L) (4) Patients with left ventricular ejection fraction less than 30% (5) Patients with renal failure (creatinine >3 mg/dl) (6) Patients with a history of liver or muscle disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse cardiac events (MACE) (Cardiac death, nonfatal myocardial infarction, stroke, target vessel revascularization, slow flow during PCI) from the procedure up to 30 days. *myocardial infarction : increase of creatine kinase-MB > 2 times above the upper limit of normal. In patients with elevated baseline levels of creatine kinase-MB, myocardial infarction was defined as a subsequent increase of more than 2-fold in creatine kinase-MB from baseline value. *Slow flow :Decline of TIMI Grade more than 1 grade during PCI
- Secondary Outcome Measures
Name Time Method (1)Any postprocedural increase of markers of myocardial injury above upper limits of normal (creatine kinase-MB, troponin-I). (2) The change from a baseline value of the following clinical markers (creatine kinase-MB, troponin-I, C-reactive protein, malondialdehyde-modified-LDL,LDL-C,HDL-C, apolipoprotein, oxidation stress ). blood sampling periods: (creatine kinase-MB, troponin-I, C-reactive protein);the day before PCI and at 8h and 24h and 30days after intervention. (malondialdehyde-modified-LDL); the day before PCI and at 24h after intervention. (LDL-C,HDL-C, apolipoprotein, oxidation stress); the day before PCI and at 24h and 30days after intervention. (3)The change of the platelet aggregation ability. blood sampling periods : the day before PCI and before PCI and at 24h and 30day after intervention. (4)Evaluation of the plaque by IVUS. (5)The patients with an additional written consent will be followed up for an additional year to investigate the incidence of MACE (primary end-point).