Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Procedure: transradial coronary intervention

• Registration Number: NCT00952770
• Lead Sponsor: Chungnam National University

Brief Summary

The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-04
• Last Update Submitted: 2009-08-04
• Study First Posted: 2009-08-06
• Last Update Posted: 2009-08-06
• Primary Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients undergoing coronary intervention via the radial artery

Exclusion Criteria

• Contraindication to statins
• Left ventricular ejection fraction less than 30%
• Recent history of hematologic disease or leukocyte count <3000/mm3 and/or platelet <100 000/mm3
• Hepatic dysfunction with AST or ALT >3 times the upper normal reference limit
• History of renal dysfunction or a serum creatinine level >2.0 mg/dL
• Serious noncardiac comorbid disease with a life expectancy <1 year
• Inability to follow the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin/Ezetimibe	transradial coronary intervention	Group receiving simvastatin/ezetimibe 10/10mg
Atorvastatin	transradial coronary intervention	Group receiving atorvastatin 20mg/day

Primary Outcome Measures

Name	Time	Method
Difference of IMT between two groups	1 month, 6 months

Secondary Outcome Measures

Name	Time	Method
Difference of epicardial fat thickness Difference of cholesterol level	6 months

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of