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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: transradial coronary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Group receiving atorvastatin 20mg/day | Procedure: transradial coronary intervention<br>* percutaneous coronary intervention with transradial approach<br>|
| Active Comparator: Simvastatin/Ezetimibe<br>Group receiving simvastatin/ezetimibe 10/10mg | Procedure: transradial coronary intervention<br>* percutaneous coronary intervention with transradial approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of IMT between two groups |  | 1 month, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of epicardial fat thickness Difference of cholesterol level |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Coronary intervention, intima-media thickness