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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00952770
• Other study ID #: CNUH-09-07-60
• Status: Unknown status
• Phase: Phase 4
• First received: August 4, 2009
• Last updated: August 4, 2009
• Start date: July 2009

Study information

• Verified date: August 2009
• Source: Chungnam National University
• Contact: Jae-Hyeong Park, MD, PhD
• Phone: 82-42-280-7167
• Email: jaehpark[@]cnuh.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• transradial coronary intervention
percutaneous coronary intervention with transradial approach

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Chungnam National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of IMT between two groups		1 month, 6 months
Secondary	Difference of epicardial fat thickness Difference of cholesterol level		6 months